4,892 Clinical Research Associate jobs in the United States

Clinical Research Associate II/ Senior Clinical Research Associate

75001 Addison, Texas Precision for Medicine

Posted 3 days ago

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Clinical Research Associate II/Senior Clinical Research Associate

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will have a lower than average number of protocols, setting you up to be a protocol expert. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a smaller CRO allows you to have influence and impact when it matters most and support from direct line management.

We are looking for an experienced CRA II or Senior CRA to join our team in France. You will have previous monitoring experience for Oncology clinical studies in France and you will be located in Paris or Paris area. This is a remote based position with travel to sites for monitoring visits.

About you:

  • You are calm, thoughtful, and responsive when things don't go as planned.
  • You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
  • You find quick and creative ways of overcoming difficulties.
  • You have an impeccable eye for detail.
  • You identify potential study risks and propose solutions on how to mitigate them.
  • You take responsibility in the quality and outcomes of your work.
  • You are adept at handling conflict by using tried and true resolution strategies.

How we will keep you busy and support your growth:

You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.). Senior CRAs handle appropriately sized clinical trials, and support Project Managers with trials that are larger in scope. You will also have the opportunity to train and mentor junior staff members. You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.

Requirements:

  • Life science degree and/or equivalent experience
  • CRA experience within the CRO or pharmaceutical industry (and working in Oncology). We require a minimum of 1 year experience as a CRA in Oncology, and can offer CRA II and Senior CRA titles depending on experience level.
  • Availability for domestic travel including overnight stays, as required (international travel may be required for some senior level positions)

Preferred:

  • Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
  • Two+ years of oncology experience
  • Study start up activities experience would be an advantage
  • For Senior CRAs, understanding of financial management and mentoring experience would be desirable

Please, apply in English.

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Clinical Research Associate

90079 Los Angeles, California Pacer Staffing

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Job Title : Clinical Research Associate

Location: Los Angeles, CA 90025

Start Date: 11/03/2025

Duration: 13 weeks

Schedule Shift: Day 5x8-Hour (08:00 - 17:00)

Pay Rate: $33/hr. Gross weekly : $1320

Description :

Position Summary:

This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace.

Requirements:

  • High School Diploma/GED required. Bachelor's degree preferred.
  • 1 year Clinical research related experience required.
  • Chemo, Oncology, or pharmaceutical research experience
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Clinical Research Associate

30383 Atlanta, Georgia HungaroTrial CRO

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Job Description

HungaroTrial is the largest regional CRO in Central and Eastern Europe with 10 offices in the region and USA, plus Business Development office in London, UK. Due to the expansion of our operations in the USA we are looking for CRA colleagues with at least 2 years of active monitoring experience.


As a Clinical Research Associate you will be responsible for a variety of monitoring tasks and you will have a chance to work on clinical studies in different therapeutic indications, ensuring the clinical trial is conducted in compliance with study protocol and procedures, ICH-GCP guidelines and the applicable regulations and SOPs.


Main duties and responsibilities

  • Initiate, monitor and close-out clinical studies on study sites in accordance with applicable regulations, guidelines of ICH-GCP and standard operation procedures;
  • Prepare and perform regulatory and ethics submission (drug, medical device, non-interventional) for approval in accordance with applicable regulations, guidelines of ICH GCP and standard operation procedures of HungaroTrial (e.g. able to perform initial CA and EC submissions, amendment, notification, progress and safety report submissions, contract negotiations without direct supervision);
  • Supportcontracting procedure between Sponsor and Investigational sites;
  • Perform feasibilities and pre-study evaluations ;
  • Document activity in accordance with ICH-GCP and standard operation procedures of HungaroTrial;
  • Prepare a summary (report) of activities as requested by the Manager.


Requirements

  • Bachelor degree in life sciences
  • at least 2 years experience in CRA role
  • experience in Oncology clinical trials
  • native level of English
  • Confident IT skills
  • Driver’s license
  • effective communication, customer focus, teamwork, time management, motivation to learn and develop


What we can offer

  • Attractive and competitive salary
  • Dedicated and supportive team
  • Multinational environment
  • Regular team buildings and company events


We take special attention to the balance of the work and your private life.

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Clinical Research Associate

85718 Tucson, Arizona PSG Global Solutions

Posted 3 days ago

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Job Description

Clinical Research Associate

Real Life Sciences' dedicated pharmaceutical and biotechnology division has been working with pharmaceutical companies, biotechnology organizations, and professionals across both sectors since 1998 and has focused on providing added-value recruitment services for companies working within development phases 1 to 4.

We work with large multinational companies, generics and biosimilar manufacturers, small niche biotech organizations, and all parts of the pharma and biotech supply chain, including R&D companies, clinical research organizations, manufacturing companies, marketing and medical communications agencies, and regulatory affairs consultancies.

Real Life Sciences' success within pharma and biotech recruitment is based on our ability to understand our key markets and develop a business that is focused on supporting our customers as their challenges change and the industry evolves.

Job Description

Position Summary:

Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays, and biomarkers developed by Ventana Medical Systems. Works closely with study managers and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring, and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).

Essential Functions:

  • Conducts in-house monitoring, and may independently perform on-site monitoring in accordance with Roche and Ventana Standard Operating Procedures, ICH GCP guidelines, and Regulations.
  • Participates in assessing study risks.
  • Communicates on behalf of the study manager with investigators and site staff.
  • Prepares study performance reports and provides input into study budgets.

Study Implementation:

  • Assists in preparation and independent execution of:
  • Study training presentations for investigators and site staff.
  • Study supply ordering and shipping.
  • Investigational product release, labeling, accountability at study sites.
  • Site Readiness and Site Monitoring Plans.
  • Assay transfer and assay qualification activities.
  • Study records including site and trial master files.
  • Site qualification, site initiation, routine monitoring, and close out visits and reports.
  • Document compilation for clinical study reports and document archive activities.
  • Data management activities including user acceptance testing, data entry, and data verification as needed.

Departmental Roles:

  • Works within project teams to facilitate the conduct of standard study designs.
  • Participates in clinical affairs meetings and completes independent activities to support departmental functions.
  • Completes all internal training programs in a timely manner, and demonstrates professional development via independent reading, networking, and training.
  • Adopts clinical practices that promote Quality First Time.
Qualifications

Formal Training/Education:

Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience.

Experience:

  • 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience required or equivalent combination of education and experience.
  • Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred.
  • A background in biomedical/healthcare services with laboratory experience preferred.

Knowledge, Skills and Abilities:

  • Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).
  • Excellent writing and verbal communication skills.
  • Well organized and detail oriented.
  • Impeccable record keeping and filing skills.
  • Excellent time management skills.
  • Ability to give presentations and teach others.
  • Ability to work effectively in a team, and also work independently on assigned tasks.
  • Ability to complete intermittent overnight travel up to 30%.
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Clinical Research Associate

94566 Pleasanton, California Calyxo USA Inc

Posted 3 days ago

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Job Description

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

The Clinical Research Associate (CRA) position at Calyxo offers a unique opportunity to build a dynamic career in clinical research while supporting innovative technologies that improve patient outcomes and have a meaningful impact in the treatment of kidney stones.

The CRA is responsible for monitoring and overseeing the conduct of clinical trials to ensure compliance with the study protocol, Good Clinical Practice (GCP), and all applicable regulatory requirements. The CRA is a key contributor to the successful execution of Calyxo's clinical research activities.

In This Role, You Will:

  • Conduct qualification, initiation, monitoring, and closeout visits at research sites.
  • Responsible for site management and primary point of contact for site staff including coordinators, clinical research physicians, and their site staff.
  • Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
  • Conduct source documentation verification and review of medical records against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
  • On-site and remote monitoring activities with a risk-based monitoring approach to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward.
  • Verification that the investigator is enrolling only in eligible subjects.
  • Regulatory document review and filing in Trial Master File
  • Perform medical device and/or investigational product accountability and inventory.
  • Verification and review of adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
  • Oversee the clinical research site's patient recruitment and retention success and provide recommendations for improvement when needed.
  • Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
  • Escalate critical issues or ongoing non-compliance to the appropriate internal stakeholders and/or project leadership in accordance with SOPs and regulatory guidelines to ensure subject safety and data integrity.

Who You Will Report To:

  • See organizational chart

Requirements:

  • Must have a minimum of a bachelor's degree in a health or science related field.
  • Minimum of 2 years' experience in industry-sponsored clinical trials as a CRA or Clinical Research Coordinator (CRC).
  • Minimum of 1 year (12 months) independent CRA monitoring experience in a full-time CRA role with a contract research organization (CRO) or industry sponsor.
  • Work location: Remote; candidate.
  • Travel: Ability to travel up to 50-60% nationwide
  • Full time
  • Proven ability to establish and maintain strong, collaborative relationships with site staff, including study coordinators and Principal Investigators (PIs).
  • Strong self-management skills with the ability to work autonomously and prioritize tasks effectively in a remote setting.
  • Demonstrated ability to engage constructively in a team setting, fostering collaboration, and contributing to achieving project milestones.
  • Effective communication and conflict-resolution skills.
  • Knowledge of Microsoft Office.
  • Broad knowledge of medical terminology.
  • Basic knowledge of medical device approval pathways.
  • Excellent oral and written communication skills.
  • Strong presentation skills.
  • Must be detail oriented.
  • Knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
  • Compliance with relevant county, state, and Federal rules regarding vaccinations.

Preferred Qualifications:

  • Live within one hour of a major airport
  • Prior urology clinical trial experience

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer an attractive compensation package, which includes:

  • A competitive base salary of $80,000 - $92,000 and variable incentive plan
  • Stock options - ownership and a stake in growing a mission-driven company
  • Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.

Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Disclaimer:

At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

  • Structured Interview Process : Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
  • Verification of Identity : We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
  • Beware of Scams : Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of If you receive a request for information from any other domain, please contact us directly at verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.

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Clinical Research Associate

Missouri, Missouri Saint Louis University

Posted 3 days ago

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Job Description

Job Summary

Under general supervision, the clinical research associate (CRA) will be responsible for oversight of clinical trials for the SLU School of Medicine. Responsibilities include screening, recruiting and enrolling subjects, conducting subject research visits, providing technical and administrative expertise in the preparation and administration of investigational products (imaging & therapy) in research subjects, data collection and data entry, detailed source documentation, maintenance of study documents, and review of budgets in coordination with the Clinical Trials Office. The CRA will liaise with core offices including the Clinical Trials Office, SLU Institutional Review Board, SLU Radiation Safety Committee & SSM Research Compliance Office as well as industry sponsors and associated CROs/vendors. The position will require the ability to collaborate with departmental as well as non-departmental team members and other research professionals in a manner consistent with St. Louis University's core values.

Primary Job Responsibilities
  • Screens, recruits and enrolls patients into research studies in accordance with good clinical practice.
  • Schedules and conducts research study visits.
  • Provides technical and administrative expertise in the preparation and administration of investigational products.
  • Records and documents study visits utilizing ALCOA+ principles.
  • Data entry and query resolution.
  • Maintains accurate and complete study documents.
  • Liaises with Clinical Trials Office, SLU Institutional Review Board, SLU Radiation Safety Committee & SSM Research Compliance Office.
  • Liaises with industry sponsors, CROs and vendors.
  • Attends meetings, performs other duties as assigned.
  • Performs other duties as assigned.
Knowledge, Skills, and Abilities
  • Knowledge of regulations and guidelines related to clinical research
  • Working knowledge of clinical research terminology and multiple medical conditions
  • Knowledge of GE Centricity, EPIC, Clinical Conductor CTMS and other University Electronic Data Systems
  • Ability to efficiently operate computer software for Electronic Health Record and Practice Management Systems
  • Strong interpersonal and customer service skills
  • Excellent time management, organizational and multitasking skills
  • Ability to maintain confidentiality
Minimum Qualifications
  • Bachelor's degree; supplemented with two (2) years of related work experience
Preferred Qualifications
  • CNMT Certification

Function: Clinical Research

Scheduled Weekly Hours:

40

Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at .

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Clinical Research Associate

06877 Ridgefield, Connecticut McInnis Inc.

Posted 3 days ago

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Job Description

Clinical Research Associate

The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with overall study execution. The CRA may also assist with data management, vendor management and site monitoring as needed.

Duties and Responsibilities
  • Act as the primary point of contact with assigned clinical study sites during start-up activities;
  • Working with finance and legal experts, drive contract and budget negotiations (or amendments) with assigned sites;
  • Review site-level documents needed for IRB/EC/REC approval;
  • Support study initiation, monitoring, audit and close-out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
  • Ensure clinical study site documentation compliance according to GCPs, ICH and FDA regulations;
  • Provide relevant, timely study subject updates to the Clinical Study Manager(s) (e.g., upcoming treatment dates, subject withdrawals, etc.);
  • Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
  • Collaborate with clinical study site and sponsor to troubleshoot and provide appropriate solutions to study-related issues, as appropriate;
  • Assist in patient recruitment activities;
  • Assist with the development of study-related documents as requested;
  • Prepare accurate and timely study reports as requested;
  • Work independently and under general supervision.

Education

  • Bachelor's degree (or higher) in nursing, health sciences or related field;

Qualifications

  • Experience with clinical trial contract and budget negotiations
  • Finance experience preferred
  • Minimum of two years of CRA experience, with clinical site monitoring experience preferred;
  • Strong oral and written communication skills;
  • Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance;
  • Proven organizational skills and the ability to manage multiple priorities;
  • Strong computer skills;
  • Ability to travel with adequate prior notification
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Clinical Research Associate

20849 Rockville, Maryland REGENXBIO Inc.

Posted 3 days ago

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Clinical Research Associate

Rockville, Maryland

Medical Organization Clinical Operations / Full Time / Hybrid

Who We Are

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The Opportunity

As a Clinical Research Associate (CRA), you will be responsible for the support and coordination of the logistical aspects of clinical trial management, site management, data review & cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs. You'll act as a pivotal point of contact for the clinical trial team and assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned.

What You'll Be Doing

  • Under moderate supervision, support and coordinate logistical aspects of clinical trials
  • Assist in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids)
  • Assist with preparation of training workshops, Investigator/Advisory Board meeting materials
  • Assist with all phases of clinical trial activities (e.g. start-up, conduct, and close-out)
  • Develop study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets)
  • Maintain tracking spreadsheets/databases and provides routine reports/dashboards to study team members
  • Request PO independently, may review invoices with oversight from Clinical Project Manager (CPM)
  • Track essential documents and maintain/review the eTMF under the guidance of CPM.
  • Assist with management of investigational product and study supplies by ensuring the accuracy of shipments of study-related materials and collection of regulatory documents required for IP release
  • May attend co-monitoring visits or other site visits based on experience and training provided by and under guidance of CPM or designee
  • Assist the CPM with the review of clinical database and management of flow of data, including but not limited to facilitating resolution of queries
  • Assist with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 reports)
  • Assist with filing and management of the Electronic Trial Master File (eTMF)
  • Distribute meeting agendas, prepare and distribute final meeting minutes including documentation of action items
  • May assume a specialized administrative role (e.g. SOP Administrator)
  • Travel up to 5% of the time is required
  • It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.

What We're Looking For

  • Bachelors degree required; scientific discipline or related healthcare field is strongly preferred
  • Minimum 1 years clinical research experience (e.g. pharmaceutical, biotechnology, CRO healthcare setting)
  • Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations, GCP/ICH R2
  • Demonstrate core understanding of medical terminology or clinical trial activities
  • Must have working knowledge and understanding of clinical protocols, and all other associated study related documents
  • Advanced knowledge of MS Office including Word, Excel and Power Point and Outlook
  • Knowledge of the principles and practices of computer applications in database management
  • Must have a high degree of customer focus toward internal and external stakeholders
  • Must display strong analytical and problem-solving skills
  • Strong interpersonal and relationship management with the cross-functional team and external vendors skills
  • Clear and concise verbal and written communication skills
  • Strong attention to detail and organizational skills required
  • Ability to establish priorities, excellent sense of urgency to manage multiple tasks and deadlines

Why You Should Apply

By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients. In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.

We are proud to offer a comprehensive rewards package which includes a market-competitive base salary, an annual performance-based bonus program, stock grants at all levels, and benefits such as health, dental, and vision insurance, retirement plan with 401(k) match, summer hours, and more! The estimated compensation range for this role is $90,000 to $120,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience.

In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and have access to development resources to help you grow personally and professionally.

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Clinical Research Associate

New
94606 Oakland, California Alameda Health System

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Job Description

Clinical Research Associate
+ Oakland, CA
+ Highland General Hospital
+ HGH Opioid Use Disorder Grant
+ Services As Needed / Per Diem - Day
+ Allied Health
+ $57.84/HR
+ Req #:
+ FTE:0.01
+ Posted:Yesterday
**Summary**
**SUMMARY:** Under direction of the Manager of Grants & Special Projects, the Clinical Research Associate coordinates all aspects of clinical trials within the assigned unit.at the Adult Immunology Clinic, Highland Campus. In consultation with providers and other clinical personnel, is responsible for selecting, implementing and monitoring clinical trials, educating, and when appropriate, enrolling patients into the various programs. Performs related duties as required.
**DUTIES & ESSENTIAL JOB FUNCTIONS:** NOTE:The following are the duties performed by employees in this classification. However, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification.
CLINICAL TRIALS:Responsible for assisting in the selection and administration of appropriate clinical research trials by reviewing studies, adhering to federal regulations and ICH Guidelines, with an emphasis on good clinical practice and clinical Safety Data Management. Administers informed consent, enrollment of participants into clinical trials.
INSTITUTIONAL REVIEW BOARD (IRB):Acts as departmental representative at Institutional Review Board's Human Subject Committee meetings. Presents all new research projects to the committee. Modifies, renews and closes out all appropriate research projects. Reports all serious adverse events and protocol violations. Submits drug and/or device safety reports to the IRB.
REGULATORY:Organizes research team and meets as needed. Maintains current CVs and licenses for all study investigators. Updates regulatory binders for each research study. Provides central protocol and drug information to departments. Educates hospital personnel regarding protocols and screening requirements. Reports serious adverse events to study sponsor and FDA, when appropriate. Ensures compliance with all federal and state laws regarding research and confidentiality. In collaboration with nursing staff, assures that operations are in compliance with external guidelines, statutory and accreditation parameters including JCAHO, Title 22, HCFA, OSHA, and other laws/regulations
PRESENTATION AND PUBLICATIONS:Assists investigators in the preparation of manuscripts and the design of posters and oral presentations for annual conventions, conferences and trainings, when appropriate. Performs searches through existing medical literature.
ADMINISTRATIVE/FISCAL:Organizes research team (nurses, co-investigators) and meets with team, as needed. Maintains current CVs and licenses for all sub investigators and binders for each protocol. Acts as the point person for budgetary and administrative issues. When appropriate, prepares and negotiates study budget. Monitors and accounts for all study related income and expenses. Requests and administers patient compensation and petty cash. Provides scheduled accounting of research funds to department directors. Interacts with AHS staff in a professional and courteous manner. Supervises research personnel to ensure compliance with protocols. Obtains, interview, and directly supervise research department volunteers and medical students on research elective rotations.
**MINIMUM QUALIFICATIONS:**
Education:Bachelor's Degree (180 quarter units or 120 semester units) with major coursework in health and human sciences, biology or a field related to the work. (Additional experience as outlined below may be substituted for the education on a year-to-year basis.)
Minimum Experience:Possess experience and expertise in medical research. Experience and expertise can be gained by "hands-on experience" in a medical or scientific setting, as a graduate or medical student or other medically trained individual. Typically equal to the equivalent of two years of full-time experience as a Clinical Research Associate or equivalent level position at a public hospital, medical center or HMO.
Required Licenses/Certifications:BLS - Basic Life Support Certification issued by AHA-American Heart Association.
_PAY RANGE: $57.84/HR_
_The pay range for this position reflects the base pay scale for the role at Alameda Health System. Final compensation will be determined based on several factors, including but not limited to a candidate's experience, education, skills, licenses and certifications, departmental equity, applicable collective bargaining agreements, and the operational needs of the organization. Alameda Health System also offers eligible positions a generous comprehensive benefits program._
Alameda Health System is an equal opportunity employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military background.
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Clinical Research Associate

95054 Santa Clara, California Actalent

Posted 2 days ago

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Job Title: Clinical Research Associate II
Job Description
The Clinical Research Associate II plays a pivotal role in the setup, activation, maintenance, and closure of global clinical trials. This position offers an opportunity to gain valuable experience in clinical trial management processes. The CRA II collaborates with Investigators, Site Personnel, and Vendors to ensure adherence to protocols and clinical objectives. Additionally, they maintain consistent CRF data quality and discrepancy interpretation across multiple sites while developing a foundational understanding of the disease and indication.
Responsibilities
+ Participate in study design and setup activities.
+ Prepare and review monitoring reports per SOPs.
+ Support the development of study training and provide training to site personnel and internal employees.
+ Assist in the development of CRF design, guidelines, and database development.
+ Develop study tools and guidelines for use by study sites.
+ Evaluate and select potential investigators, sites, and vendors.
+ Interact with field monitors, CRAs, investigators, and study coordinators to manage study issues.
+ Perform data entry and trend analysis in the clinical database.
+ Draft informed consent forms and ensure compliance with GCP requirements.
+ Coordinate and review regulatory documents from study sites.
+ Track Safety Reports for assigned sites and ensure audit readiness.
+ Author internal documents and contribute to clinical study and evaluation reports.
+ Initiate device shipments and manage study supply inventory.
+ Handle investigator contract, budget, and payment processes.
+ Track quarterly site payments and reconcile study invoices.
+ Communicate trial status to manager and team.
+ Develop or revise SOPs or work instructions as needed.
+ Represent the functional area appropriately.
Essential Skills
+ Bachelor's degree in a scientific field with a minimum of 2 years of experience in clinical research.
+ Excellent verbal and written communication skills.
+ High attention to detail and strong organizational skills.
+ Basic understanding of peripheral and coronary artery diseases and therapies.
+ Working knowledge of GCP, FDA, ISO, and other applicable regulations.
+ Ability to travel 10-20% domestically and internationally.
+ Experience with EDC Data Management Systems.
+ Ability to manage multiple priorities in a fast-paced environment.
+ Flexibility to work independently or as part of a team.
Additional Skills & Qualifications
+ ACRP or SOCRA clinical research certification preferred.
+ Experience with medical devices and cardiovascular studies is preferred.
+ Proficiency in Excel, including pivot tables.
+ Experience with Angio tracker and cardiac imaging.
+ Familiarity with SmartSheets and SharePoint.
Pay and Benefits
The pay range for this position is $40.00 - $50.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Oct 10, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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