Role Description
The Clinical Trial Assistant (CTA) supports the planning, coordination, and execution of clinical research studies. This role ensures that clinical trials are conducted in compliance with regulatory requirements, study protocols, and internal procedures. The CTA works closely with clinical research associates (CRAs), study managers, investigators, and sponsors to maintain accurate documentation and facilitate smooth trial operations.
Essential Responsibilities and Duties
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Assists in the preparation, collection, and maintenance of clinical trial documentation (e.g., Trial Master File (TMF), Investigator Site Files (ISF)).
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Tracks and manages study-related documents, ensuring completeness and compliance with regulatory standards (e.g., FDA, ICH-GCP).
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Supports study start-up activities, including site selection, regulatory submissions, and ethics committee documentation.
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Coordinates communication between study teams, sponsors, and investigational sites.
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Maintains study tracking tools, including timelines, enrollment status, and site performance metrics.
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Assists with scheduling meetings, preparing agendas, and documenting meeting minutes.
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Supports monitoring visit logistics and follow-up actions.
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Ensures proper filing, archiving, and version control of study documents.
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Assists in safety reporting and tracking adverse events, as required.
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Assists with financial tracking, including invoice review and matching against Clinical Trial Agreement, budgets and visit schedules / milestones.
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Provides administrative support to the clinical operations team.
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Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working practices, protocol, and company guidelines and policies.
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Assumes other duties and responsibilities as assigned.
Qualifications
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Bachelor’s degree in life sciences, healthcare, or a related field (preferred).
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1–2 years of experience in clinical research.
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Knowledge of clinical research processes and regulations (e.g., ICH-GCP guidelines).
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Working knowledge of CTMS (e.g. Clinical Conductor or similar).
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Working knowledge of e-TMF or e-ISF systems (e.g. Florence or Veeva Vault).
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Strong organizational and time management skills.
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Attention to detail and accuracy in documentation.
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Effective written and verbal communication skills.
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Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
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Ability to manage multiple tasks and meet deadlines.
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Must be able to effectively communicate verbally and in writing.
Requirements
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Essential physical requirements include sitting, typing, standing, and walking.
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Lightly active position, occasional lifting of up to 20 pounds.
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Reporting to work, as scheduled, is essential.
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Remote work arrangement.
Compensation
$22.25 - $26.97/h depending on education, experience, and skillset.
Company Description
CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
