8,706 Clinical Trial Coordinators jobs in the United States

If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research and development, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs, as well as for our partners across major therapeutic areas. Senior Clinical Trial Associate/Clinical Trial AssociateApply Summary of Position Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF). Key Responsibilities Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation. Set up and maintain study-specific paper and electronic TMFs. Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices. Track and report CRO's ability to maintain TMF health metrics on an ongoing basis. Process essential documents and ensure they are correctly filed in the appropriate TMF. Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed. Participate in GxP audits and related clinical operations compliance and inspection readiness activities. Prepare and track study documents (e.g., contracts, budgets, IRB documentation). Assist with information gathering, literature searches, and creation of presentations, as needed. Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.) Administer user access and change control within Anavex's electronic systems. Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems. Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards. Assist with vendor management and associated logistics, as assigned. Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations. Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies. Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel) Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual. Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management. Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF. Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information. Assist in creating and implementing departmental SOPs and procedures. The position will be filled at a level commensurate with experience. Requirements BS/BA in Life Sciences or equivalent 3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinical research organization environment Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/ QR, and query management. Familiar with the DIA reference model Knowledge of ICH/GCP and applicable regulations Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global) Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox Strong critical thinking, organizational and time-management skills Ability and willingness to travel (up to 10% of the time) Your Path to Unique Opportunities If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, pain, and various types of cancer. Further information is available at . EOE/M/F/V/SO Anavex Life Sciences Corp. is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status. Visit anavex.com/eeo-policy-statement to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Stay ConnectedFollow us on social media Letter from the CEO Our Values Contact Us

About Soleno Therapeutics Inc

Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, including Prader-Willi syndrome (PWS).

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are it is in our chromosomes and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way.

Our employees are our most important asset, and we are looking to expand across many functions during this important and pivotal time. We encourage you to join us in making history. We all share the most important goal of bringing solutions to the PWS community. They are waiting.

Summary of Job (brief description)

The Clinical Trial Manager reports to Solenos Senior Director, Clinical Operations and is a key leader in the Clinical Operations department contributing to the execution of Solenos clinical trials across all phases, in accordance with company goals and budgets. This individual will work closely with various internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with the protocol(s), SOPs, ICH GCP, regulatory authorities regulations/guidelines, and applicable SOPs. This role requires adaptability and willingness to travel domestically and internationally as needed to support trial execution.

Responsibilities

• Manages the operational aspects of clinical trials including but not limited to timelines, budget and resources.
• Works closely with the Senior Director, Clinical Operations to ensure adequate resourcing and trial support.
• Participates in and facilitates Contract Research Organization (CRO) and vendor selection processes for outsourced activities.
• Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• Manages CRO and vendor interactions, including sponsor oversight of operational functional activities (e.g., trial management, site monitoring and management, project master files) to ensure compliance with the contracted trial specifications and applicable SOPs.
• Participates in development and review of protocol, case report form (CRF) development, trial plans, Clinical Study Report preparation, and New Drug Application / Marketing Authorization Application (NDA/MAA) submissions, as appropriate.
• Prepares, reviews and approves trial-related tools, worksheets and documents (e.g., informed consent template, Clinical Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).
• Prepares trial metrics and updates for management, as assigned.
• Proactively identifies potential trial issues, mitigates risks, recommends and implements solutions to ensure compliance with the protocol, SOPs, regulatory requirements and ICH GCP guidelines.
• Reviews and approves investigator clinical trial agreements and site payments.
• Organizes, attends, and manages internal team meetings, CRA meetings, investigator meetings, CRO meetings and other trial-specific meetings.
• Drives investigator selection process by development of potential investigator listing and customization of trial specific tools (e.g., Site Profile, Site Feasibility Questionnaire and pre-trial tracker).
• Works with CRO or assigns clinical research associate (CRA) to conduct pre-trial contact, review pretrial contact reports and vetting documentation to ensure compatibility with the requirements of the proposed trial.
• Provides input to the Project Director (PD) regarding investigator and site selection, notifies investigators of participation status.
• Collaborates with the trial team and CRO as appropriate to monitor trial recruitment and strategies, monitoring visits and reports, data quality, and escalation of serious GCP noncompliance or protocol deviations.
• Participates in CRA selection, training and transition process for any site re-assignments.
• Manages monitoring performance issues by report review and observation visits and escalates any significant findings.
• Notifies the PD of any important protocol deviations reported by CRA and facilitates follow-up as specified in the Project Management Plan.
• Works directly with the CRA and with the CRO Project Manager and PD to resolve persistent or significant non-conformance issues at clinical trial sites and recommend removal when appropriate.
• Oversees investigational product (IP) accountability to ensure activities and records document a product chain of custody to track IP from time leaving the depot until time used by a participant, destroyed onsite, or returned to depot.
• Verifies quality checks and reconciliation of the (electronic) Trial Master File (TMF) documents is completed according to the trial TMF plan.
• Participates in the development, review and implementation of departmental SOPs and processes.
• Recommends and implements innovative process ideas to enhance clinical trials management and be feasible and promote improvements from a monitoring perspective.
• Participates in the selection, development, training, management and evaluation of trial personnel (contract and internal) to ensure the efficient operation of the function.
• Oversees Clinical Trial Associate activities (e.g., site activation, investigational product release, essential document filing) to ensure timely trial start-up and conduct.
• Participates in inspection readiness and audit reviews and ensures implementation of corrective and preventative actions, as applicable, within specified timelines.
• May manage clinical operations staff and contribute to yearly evaluations, provide development opportunities and address any performance issues identified.
• Performs other duties as assigned.

Qualifications

• A Bachelor of Science degree required.
• A minimum of 6 - 8 years of related clinical trial management experience.
• Must have strong Phase 1 clinical trial experience, including oversight of first-in-human or proof-of-concept studies.
• Demonstrated experience with the unique operational and regulatory considerations of early-phase trials.
• Rare Disease experience preferred.
• Experience in managing outside vendors (e.g., CROs, central laboratories, and other vendors)
• Strong knowledge with advanced concepts of clinical research and able to work effectively in a team environment.
• Strong knowledge and experience with clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required.
• Ability to provide clinical operations expertise in a specified product area or project.
• Excellent written and verbal skills required. Must display strong analytical and problem-solving skills. Attention to detail required.
• Proficient in MS Suite.
• Demonstrated leadership to drive results that are needed to achieve company objectives.
• Must possess excellent interpersonal skills.
• Must have the ability to build and maintain positive relationships with management, peers, and direct reports.
• Ability to deal with time demands, incomplete information or unexpected events.
• Ability and willingness to travel domestically and internationally as required by trial needs.

Salary Range: $145,000 - $185,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidates relevant qualifications, skills, and experience, as well as the location where this position may be filled.)

• Ensure all tasks comply with Good Clinical Practice (GCP) and regulatory guidelines
• Maintain effective collaboration with internal and external stakeholders
• Structure, manage, Quality Control (QC) review and provide detailed oversight of Merus's clinical trial document filing system (eTMF and/or physical) including follow-up on metrics and remediation of any noted deficiencies from internal and external review processes
• File and (QC) essential clinical trial documents for assigned trials
• Instruct and support CTAs on QC and filing procedures (Sr. CTA responsibility)
• Maintain and monitor access to Microsoft TEAMS channels, share point sites, and any relevant clinical systems, trackers, training tools etc. for both internal and external members; regularly review access permissions and content
• Coordinate and schedule meetings including room reservations and dial-in/virtual access details, as well as provide detailed minutes and finalized agendas for multiple meetings
• Lead onboarding for Clinical Operations project staff, including system access requests and GCP and study training setup
• Initiate monthly project compliance dashboard updates for assigned studies and work to finalize updates with oversight from the Clinical Trial Manager (CTM) and / or Project Director (PD)
• Initiate requests and track project Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and Purchase Orders (PO) for assigned project
• Maintain Clinical Trial Trip Report Review Tracker in collaboration with the CTM assigned to review reports. Initiate follow-up with Clinical Research Organization (CRO) on remediation of findings.
• Completion of ClinicalTrials.Gov postings as necessary according to processes, with detailed oversight from CTM / Project Director assigned
• Maintenance of an actions decisions log (ADI log) for assigned project covering all internal meetings and provision of follow-up of remediations with CTM oversight

• Support in locating and providing scientific, clinical, or regulatory literature
• Respond to documentation requests and assist with document archiving for audits, inspections, and internal reviews

• Assist in generating standard outputs and reports and documenting necessary follow-up from electronic Case Report Forms (eCRFs)
• Support documentation and tracking of ongoing data reviews
• Follow up with CROs for monthly protocol deviation (PD) listings and ensure monthly meetings of PD review with leadership and oversight from the CTM

• Track and manage Confidentiality Agreements (CDAs) and Clinical Trial Agreements (CTAs) in Veeva Vault
• Maintain and update trackers; coordinate follow-ups with CROs and internal stakeholders
• Review, track, and file vendor invoices; support invoice-related communication and management

• Process internal sign-off cascades for the IMP Release Checklist (GLP Checklist) and maintain filing status trackers
• Track and follow up with CROs regarding temperature monitoring logs and documentation for drug shipments to clinical sites

• Assist in procuring clinical trial-related resources (books, articles, training)
• Support creation and maintenance of Purchase Orders (POs) in SAP
• Ensure accurate filing and tracking of vendor invoices

• Support preparation of newsletters and updates for clinical trial sites
• Create summaries and reports to support trial site engagement and performance tracking

• Participate in global clinical project and trial team meetings; prepare meeting minutes when requested
• Attend internal Clinical Operations meetings and record meeting minutes as needed

• Assist in drafting, reviewing, and updating Standard Operating Procedures (SOPs)
• Submit and track access requests for shared file systems (e.g., SharePoint) on behalf of the Clinical and Translational Science teams

• Bachelor's degree in Biomedical Sciences, Life Sciences, or a related field
• Strong proficiency in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint)
• Working knowledge of GCP, ICH guidelines, and clinical documentation requirements
• Familiarity with clinical systems including Veeva Vault, eTMF, SAP, and SharePoint is a plus
• Strong attention to detail with excellent organizational skills and the ability to manage multiple priorities
• Clear and professional written and verbal communication skills

Medpace is the leading CRO for Biotech companies and is continuing to add senior-level Directors and established Project Managers to join our Clinical Trial Management Group in Cincinnati, OH, or remotely with relevant experience. Therapeutic area of focus is Oncology, Hematology , and more. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.

• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations.
• Serve as primary Sponsor contact for operational project-specific issues and study deliverables.
• Maintain in-depth knowledge of protocol, therapeutic area, and indication.
• Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided.
• Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable.
• Develop operational project plans.
• Manage risk assessment and execution.
• Manage study vendors where applicable.
• Manage site quality and monitoring deliverables.

• Bachelors degree in a health-related field; Advanced degree in a health-related field preferred.
• Experience in Phases 1-4; Phases 2-3 preferred.
• 5+ years as a project/clinical trial manager within a CRO.
• Management of overall project timeline.
• Bid defense experience.
• Strong leadership skills.

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work weve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

• Flexible work environment.
• Competitive PTO packages, starting at 20+ days.
• Competitive compensation and benefits package.
• Company-sponsored employee appreciation events.
• Employee health and wellness initiatives.
• Community involvement with local nonprofit organizations.
• Discounts on local sports games, fitness gyms, and attractions.
• Modern, eco-friendly campus with an on-site fitness center.
• Structured career paths with opportunities for professional growth.
• Discounted tuition for UC online programs.

• Named a Top Workplace in 2024 by The Cincinnati Enquirer.
• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

EO/AA Employer M/F/Disability/Vets

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Clinical Trial Enrollment Coordinator to join our diverse and dynamic team. As a Clinical Trial Enrollment Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Location: 100% on site San Antonio TX

What you will be doing:

• Collaborating with cross-functional teams to design and implement effective clinical trial enrollment strategies.
• Coordinating and overseeing the enrollment process, ensuring adherence to protocols and regulatory requirements.
• Analyzing enrollment data and identifying opportunities for process improvement to enhance efficiency.
• Communicating effectively with study sites and investigators to facilitate smooth enrollment procedures.
• Contributing to the development of enrollment-related documents and reports.

Your profile:

• Bachelor's degree in a relevant field (e.g., life sciences, healthcare, or a related discipline).
• Proven experience in clinical trial coordination, with a focus on enrollment activities.
• Strong understanding of regulatory requirements and industry standards related to clinical trial enrollment.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively within a cross-functional team.
• Detail-oriented mindset and the ability to interpret and analyze complex medical data accurately.

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Overview:

Supports the recruitment and enrollment of qualified volunteers for clinical drug trials through the review and analysis of relevant data and protocol requirements.

Primary Responsibilities:

• Maintains the feasibility of a study from a recruitment point of view during the proposal phase and communicates findings as appropriate.
• Collaborates with recruitment team to identify qualified volunteers to participate in a specific study.
• Supports the project team by consolidating training materials for the recruiting and screening departments.
• Provides updates to the project team on recruitment and screening activities and assists in maintaining accurate screening and enrollment logs.
• Reviews the recruitment and screening outcome throughout the study to ensure that full groups are dosed according to the timelines.

Additional Responsibilities:

• Assists with the creation and review of recruitment and screening documents prior to submission to the sponsor and relevant boards and committees for approval.
• Partners with specialists to review protocol inclusion and exclusion to optimize recruitment.
• Collaborates and supports recruitment feasibility on current and future studies.
• Monitors risks to subject recruitment and assists with developing contingency plans.
• Assists with the analysis of recruitment effectiveness.
• Interacts with study participants during the recruitment and screening process.

To be successful in the role, you will have:

• Good knowledge of clinical drug trials
• Good knowledge of medical terminology
• Good knowledge of work instructions, standard operating procedures and internal and external regulations
• Good written and oral communication skills
• Demonstrated ability to read and interpret study protocols
• Ability to handle confidential information

Requirements:

• High school diploma or international equivalent
• 2 years of relevant experience

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.