Provide administrative and operational support across the clinical trial lifecycle.
Track study metrics (enrollment, screening, recruitment, site updates).
Assist in preparing and documenting meeting materials.
Schedule and coordinate meetings.
Prepare, ship, and track investigational products and study supplies.
Support collection, tracking, and review of essential documents.
Assist with feasibility, qualification, and regulatory document management.
Support IRB/EC submissions and ICF preparation.
Track study start-up timelines and follow up with sites and vendors.
Perform QC review of TMF documents.
File documents per TMF Reference Model.
Identify gaps, inconsistencies, and missing documentation.
Support audit and inspection readiness.
Review and enter clinical data into EDC systems.
Manage data queries, reconciliation, and quality control checks.
Support documentation review and source verification activities.
Provide customer service to clients, vendors, and sites.
Draft or update trackers, presentations, and study reference materials.
Support cross-functional initiatives and process improvements.
Participate in study meetings and assist with follow-up actions.

Requirements

Strong self-motivation, ability to work independently, and quickly learn new information and skills
Demonstrated strengths in planning, organization, time management, problem solving, and attention to detail
Strong organizational skills, the ability to manage multiple priorities, and produce accurate and timely work
Excellent oral and written communications and presentation skills; ability to communicate effectively with vendors and clients
Basic understanding of US clinical research process, FDA, regulations, and ethical guidelines preferred
Detailed knowledge of Microsoft Office suite of software programs:
Microsoft Outlook including shared calendars & invitations
Microsoft One Drive and Share Point
Microsoft Power Point
Microsoft Excel
Document change tracking & version control
Preferred: Familiarity with GCP/GDP/ICH guidelines
Experience with eTMF, EDC, CTMS, or document management systems
Prior exposure to clinical research

Benefits

health insurance
401k retirement plan
paid days off

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial lifecycle supportstudy metrics trackingregulatory document managementQC review of TMF documentsclinical data entrydata queries managementsource verificationdocument change trackingversion controleTMF

Soft Skills

self-motivationplanningorganizationtime managementproblem solvingattention to detailoral communicationwritten communicationpresentation skillscustomer service