14,678 Clinical Trial Managers jobs in the United States

We're Hiring: Clinical Research Associate!

We are seeking a detail-oriented and dedicated Clinical Research Associate to support clinical trials and ensure compliance with regulatory standards. The ideal candidate will have strong organizational skills, attention to detail, and experience in clinical research to help advance medical breakthroughs and improve patient outcomes.

Location: Valhalla, United States
Work Mode: Work From Office
Role: Clinical Research Associate

What You'll Do:
Monitor clinical trial sites and ensure protocol compliance
Review and verify clinical data accuracy and completeness
Collaborate with investigators, coordinators, and study teams
Conduct site initiation and close-out visits
? Prepare detailed monitoring reports and documentation
Ensure adherence to GCP, FDA, and ICH guidelines

What We're Looking For:
Bachelor's degree in life sciences or related field
Experience in clinical research or pharmaceutical industry
Strong analytical and problem-solving skills
Excellent written and verbal communication abilities
Knowledge of regulatory requirements and GCP standards
Willingness to travel to clinical sites

Ready to make an impact in healthcare? Apply now and let's advance medical research together!

Job Summary: Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of interim and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. This is a contract traveling CRA position if necessary. Responsibilities: Has a solid knowledge of the therapeutic area or a therapeutic background, showing adeptness to work in oncology and phase 1 studies. Performs regulatory document review and monitors adherence to the regulatory document collection process. Able to write clinical monitoring plans, source documents, and create other study tools when requested. Conducts monitoring/co-monitoring activities for interim site monitoring and closeout visits, in conformance with all relevant laws, regulations, guidelines, protocols, and internal SOPs/policies. Identifies and effectively documents site findings with the ability to re-train, place corrective action in place with the site, and follow up as required. Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. Reconciles clinical supplies and drug accountability records at study sites. Identifies and effectively documents site findings with the ability to re-train, place corrective action in place with the site, and follow up as required. Reviews, clarifies, and obtains data changes via query resolutions with site personnel. Collaborates with data management to resolve queries. Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities. Understands and implements processes for distribution and tracking of SAEs, safety documentation, and pregnancies. Monitors compliance with these processes. Facilitates investigator site payments, as applicable. Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation. Obtains a complete understanding of all trial-related documents and operational procedures. Maintains clinical trial tracking information pertaining to the study (e.g., monitoring calendar, monitoring reports, phone contacts). Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). Reviews and tracks study documents, including project files both electronically and in the Trial Master File and Project Status Reports. Communicates and interacts with relevant study personnel, including developing and maintaining collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to the study manager; troubleshoots and follows up on study progress; and reviews report data for completeness and accuracy. Assists with effective and timely audit/inspection responses. Prepares key reports and documents on the progress of the study for the study manager. Tracks study-specific tasks and progress of the trial. Reviews study and/or site-specific ICF(s) for compliance with ICH/GCP and company SOPs.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This Clinical Research Associate works remote but must be based in Illinois. We are seeking an experienced professional individual contributor to join our team and oversee the direction, planning, execution, and data collection activities of clinical trials/research. This role operates under limited supervision and requires the application of subject matter knowledge in Medical Affairs. This role will support our Abbott Diagnostics division.

What Youll Work On

• Contribute to the implementation of clinical protocols and facilitate the completion of final reports.
• Recruit clinical investigators and negotiate study design and costs.
• Direct human clinical trials (phases III & IV) for company products under development.
• Participate in adverse event reporting and safety monitoring.
• Coordinate and provide information for reports submitted to regulatory agencies.
• Monitor adherence to protocols and determine study completion.
• Coordinate and oversee investigator-initiated and group studies.
• Act as a consultant/liaison with other corporations under licensing agreements.
• Apply skills and knowledge to meet specific needs and requirements.
• Work independently while contributing to team goals.

Education and Experience

• Associates Degree in sciences with a minimum 1 year of clinical research experience.
• ACRP Certification or CCRP Certification preferred

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at abbott.com, on LinkedIn at and on Facebook at

The base pay for this position is $60,000.00 $120,000.00. In specific locations, the pay range may vary from the range posted.

Analyze process workflow; implement operational changes in coordination with Director Perform the management of 1-2 Clinical Studies at a time. - Serve as the main contact and liaison for project specific client and communicates with investigative si Clinical Research, Research Associate, Clinical, Associate, Monitoring, Research, Technology, Healthcare

Career Opportunities with Summit Therapeutics Sub, Inc.

A great place to work.

Careers At Summit Therapeutics Sub, Inc.

Current job opportunities are posted here as they become available.

*Relocation support will be considered for this role

Overview of Role:

The Clinical Research Associate (CRA) is responsible for supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial.

Role and Responsibilities:

• Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables.
• Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites.
• Initiates and builds solid professional relationships with clinical site staff.
• Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data.
• Creation and development of study trackers.
• Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings.
• Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc.
• Responsible for reviewing assigned study related plans, processes, agreements, and guidelines.
• Following and implementing assigned study related plans, processes, agreements, and guidelines.
• Responsible for requesting and logging CRO and vendor RFIs/RFPs contracts/work orders and specifications to enable study objectives to be met.
• Reviews and approves essential document packages to enable timely site activations.
• Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete.
• Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed.
• Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary.
• Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF.
• Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs.
• Ensures the study is inspection ready contemporaneously.
• Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate.
• All other duties assigned.

Experience, Education and Specialized Knowledge and Skills:

• Bachelors degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
• A minimum of 3+ years of clinical research experience in conducting clinical trials.
• Prior phase II or III experience required.
• A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process.
• Experience with clinical studies oncology and/or rare diseases a plus.
• Sophisticated understanding and highly skillful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams.
• Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%).
• Tenacity to work in a fast-paced team environment.
• Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships.
• Ability to successfully engage and work collaboratively with global team members/colleagues.
• Ability to support building and delivery of patient enrolment strategies.
• Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives.
• Ability to review and assess clinical data.
• Possesses excellent planning, time management & coordination skills.
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Experience in working in a small organization a plus.
• Excellent written and oral communication skills.

The pay range for this role is $94,500 to $111,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

About Summit

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational

About Summit

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational

bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
  
  

• Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
• Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
• Initiates and builds solid professional relationships with clinical site staff
• Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data
• Creation and development of study trackers
• Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
• Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc.
• Responsible for reviewing assigned study related plans, processes, agreements, and guidelines
• Following and implementing assigned study related plans, processes, agreements, and guidelines
• Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met
• Reviews and approves essential document packages to enable timely site activations.
• Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
• Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed
• Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF
• Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• Ensures the study is inspection ready contemporaneously
• Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate
• All other duties as assigned
  
  

• Bachelors degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
• A minimum of 3+ years of clinical research experience in conducting clinical trials
• Prior phase II or III experience required
• A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Experience with clinical studies oncology and / or rare diseases a plus
• Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
• Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
• Tenacity to work in a fast-paced team environment
• Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships
• Ability to successfully engage and work collaboratively with global team members/colleagues
• Ability to support building and delivery of patient enrolment strategies
• Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives.
• Ability to review and assess clinical data
• Possesses excellent planning, time management & coordination skills.
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Experience in working in a small organization a plus
• Excellent written and oral communication skills
  
  

• Seniority level Associate

• Employment type Full-time

• Job function Strategy/Planning and Information Technology

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About Neuralink:We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.Team Description:The Clinical Team is responsible for the development, implementation, execution, and oversight of Neuralink's human clinical trial operations. We build and manage key relationships between internal Neuralink teams and external organizations such as study sites, research partners, regulatory bodies, and other entities essential to successfully carrying out human clinical trials. Job Description and Responsibilities: As a Clinical Research Associate, you'll play a crucial role in pioneering groundbreaking clinical studies! Your work will directly contribute to the planning, execution, and success of innovative trials, from the initial phases of study setup to hands-on clinical monitoring and site management. You'll be visiting sites both in-person and remotely to ensure protocol and regulatory compliance, tackle safety event management, and maintain essential documentation. Collaborating closely with a passionate, cross-functional team, as well as external partners, you'll be at the forefront of Neuralink's mission to push the boundaries of what's possible in clinical research. Additional job responsibilities will include:Conducting qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocols and applicable regulationsVerifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staffVerifying medical record and source documentation against case report form (CRF) data, including informing the site staff of any entry errors, ensuring good documentation (GDP) practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirementsOn-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forwardAssisting in regulatory document write-up and reviewsOrganizing and submitting IRB/EC submissions and applicable regulatory documentation with follow-through to ensure successful outcomesAmending clinical study documents (ICF, CRFs, Monitoring Plan, etc.) as needed and helping clinical sites with institutional review board submission as necessaryReviewing and verifying adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with protocolAssessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement as well as helping with Sponsor recruitment activitiesCompleting monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure complianceContributing to the review of consent form language for consistency across protocolsRequired Qualifications: Bachelor's degree in life sciences or related fieldMinimum of 5 years of experience working in clinical trials with 3 years as a Clinical Research AssociateStrong understanding of GCP, FDA, and ICH guidelines, regulations, and compliance requirements (e.g., 21 CFR 812, ISO14155)Proven ability to manage multiple tasks, prioritize workload effectively, and meet deadlines in a fast-paced environmentExcellent interpersonal, communication, and organizational skillsAbility to travel domestically and internationally, as required, up to 50%Preferred Qualifications:Advanced degree in life sciences or related fieldSignificant experience in medical device studiesCertification as a Clinical Research Professional (CCRP) or equivalentProficiency in Microsoft Office Suite and familiarity with electronic data capture (EDC) systemsExperience working in a fast-paced medical device startup environmentExperience working in neuromodulation, surgical robotics, or another Class III implantable deviceExpected Compensation:The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees' success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.Base Salary Range:$89,000-$148,000 USDWhat We Offer:Full-time employees are eligible for the following benefits listed below.An opportunity to change the world and work with some of the smartest and most talented experts from different fieldsGrowth potential; we rapidly advance team members who have an outsized impactExcellent medical, dental, and vision insurance through a PPO planPaid holidaysCommuter benefitsMeals providedEquity (RSUs) *Temporary Employees & Interns excluded401(k) plan *Interns initially excluded until they work 1,000 hoursParental leave *Temporary Employees & Interns excludedFlexible time off *Temporary Employees & Interns excluded

We are seeking a full-time Clinical Research Associate to serve as Project Director (PD) of a clinical research study in people with cancer, specifically cancer survivorship, treatment-related toxicities and rehabilitation strategies. The PD will wor Clinical Research, Research Associate, Clinical, Associate, Research, Project Management, Healthcare

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.

• 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 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

• Bachelor's degree; supplemented with two (2) years of related work experience

• 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 .