Position Title: Clinical Trial Assistant

Reports To: Senior Project Manager

Job Summary:

The Clinical Trial Assistant acts as the liaison for clinical operations activities needed to support various project teams.

Major Responsibilities:

· Schedule project meetings as requested

· Participate in project meetings and create meeting minutes

· Work with the project managers to understand specific sponsor/client issues

· To coordinate clinical research study records, maintain study files and help report physician payments per PPSA (Physician Payment Sunshine Act)

· Facilitate the completion of IRB initial applications, continuing reviews and required regulatory documents

· Support studies by preparing & shipping regulatory binders & additional patient materials to sites

· Have the ability to create, manage, and maintain a database of sites, their requirements, shipping records etc.

· Coordinate with Project Managers and Project Coordinators to ensure that studies are well stocked with necessary supplies

· Assist in project related event planning, which may include off-site duties (investigator meetings, etc.)

· Assistance in maintaining study TMFs

· Manage Study Supply inventory (shipping supplies to sites, tracking inventory, ordering additional supplies as needed under the project manager’s supervision)

· Complete any other ancillary tasks assigned by the company from time to time

· Assisting project managers where needed with recruitment initiatives and tracking

· Participate as needed in special department projects

· Assist CEO with administrative, operational and technical aspects of the organization

Qualifications:

· Bachelor’s degree preferred with clinical research experience

· Excellent interpersonal and customer service skills

· Ability to communicate effectively (verbally and in written form) with multi-disciplinary groups and patients

· Demonstrated organization and time management skills

· Ability to think critically and analyze both project and overall community recruitment needs

· Working knowledge of mail processes (postage, Fedex and UPS)

· Professional appearance and manner

· Ability to lift moderate-heavy objects

· Willing and able to travel (10%)

If you are interested in applying for this job, please email your resume to bizdev@totalcro.com.