Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management
Collect, track and conduct initial review for completeness of site regulatory documents and/or TMF filing
Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking
Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
Communicate directly with sites handling triages, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with study conduct, and/or close-out activities
Assist with tracking of clinical trial progress including status update reports, as requested
Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking
Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates
May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues
Other duties as may be assigned

Requirements

A./B.S. degree required
At least 5 years of work experience supporting clinical trials
Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook
Ability to prioritize and manage competing priorities
Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners.

Benefits

Equal employment opportunities without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical trial managementregulatory document reviewTMF managementtracking spreadsheetsinvoice reviewstudy materials creationdata synthesismetrics reportingmonitoring visit trackingdata cleaning

Soft Skills

prioritizationcollaborationcommunicationteam orientationorganizational skillstime managementproblem-solvingattention to detailadaptabilitymeeting facilitation

Certifications

A.B.S. degreeICH GCP certification