Lead Clinical Study Assistant

• Kelly Services, Inc., seeks a Lead Clinical Study Assistant in Jacksonville, FL to join our team to interview potential clinical study candidates;
• Track upcoming and priority studies that will impact resourcing of staff; Announce CSA communications to the department or applicable parties;
• Facilitate bi-weekly CSA team meetings; Work closely in conjunction with the Clinical Team Lead and Sponsor Management for department organizational purposes;
• Enter and maintain required documentation in study specific databases related to purchases, contracts, health care compliance, study document management, and other areas as required;
• Responsible for the set-up of the Trial Master File, investigator study file binders and regulatory document collection;
• Responsible to review protocols, informed consent forms, and case report forms to ensure consistency and accuracy in conjunction with the CRA;
• Responsible for forecasting and calculating study specific supply needs for team; Coordinate and plan investigator meetings, site training, and other company functions;
• Facilitate weekly CSA team meetings; Review, track, scan and upload regulatory documents to eTMF and file in TMF; Request and submit Research Agreements for approval;
• Format and finalize draft protocols to Regulatory and SOP standards; Maintain the Clinical Operations Budget and review and report any changes in the transactions;

Track, reconcile, and report Clinical Study Budget and Payments to the Sites; and Utilize the following tracking and database tools : Veeva TMF, CTMS, and SharePoint.

Qualified applicants must have a Master of Science Degree in Biomedical Engineering, Clinical Research, Public Health, or a foreign equivalent.

• Qualified applicants must have at least one year of experience as a clinical researcher, clinical document manager, or a substantially similar position, performing the following duties : (1) Coordinating clinical document management activities for multiple studies, including management of internal Clinical Central Files (CCF) and electronic trial master files(eTMF);
• 2) Entering and maintaining required documentation in study specific databases related to purchases, contracts, health care compliance, and study document management;
• 3) Setting up Trial Master Files, investigator study file binders, and regulatory document collection; (4) Formatting and finalizing draft protocols to Regulatory and SOP standards;

5) Utilized the following tracking and database tools : Veeva TMF, CTMS, and SharePoint. Teleworking is permitted 50% of the time.

Qualified applicants email resumes to [email protected] and reference Lead Clinical Study Assistant in the title.