Reports to: Regulatory Manager

Directly Supervises: This position does not have direct reports

Expectation for all employees: To support the organization’s passionate cause, vision, and FUNdamentals by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect, accountability, and ownership.

Position Purpose: Facilitates professional service in clinical trials industry by processing regulatory documents efficiently; ensures compliance with all FDA regulations in research documentation; communicates professionally with IRBs, CROs, and Sponsors; maintains trial tracking documents and software.

Essential Responsibilities:

Ensure accuracy, completeness and consistency of data for submission to Sponsor, CRO and IRB in multiple clinical trials

Gather, enter and/or update data to maintain company records and databases; establish and maintain electronic files and records for sites

Submit regulatory documents and other documents, as necessary, on behalf of the Affiliate sites

Obtain appropriate documentation to support submission of Affiliate Site to Sponsor, CRO and IRB including Principal Investigator’s signed and dated CV, copies of medical license and practice demographics

Assist in maintaining current regulatory documents during the entire clinical trial process

File new or revised documents electronically into Regulatory/Shared drive on computer

Communicate all regulatory needs (update CVs, request IATA and GCP certificates, verify licenses and local lab documentation) to Clinical Research Coordinators in a timely manner, and remind Clinical Research Coordinators of actions to be taken with the documents

Prepare documents for regulatory binders and send documents to Affiliate Sites for filing

Facilitate GCP training as needed. Work closely with the staff to ensure that all outside physicians and/or staff complete in timely manner

Assist Clinical Research Coordinators by providing documentation to Sponsors/CROs upon request

Create spreadsheets to track and request regulatory documents prior to expiration

Assist Clinical Research Coordinators in clinical trial Continuing Review and Close-out process by completing and submitting documentation to IRB.

Serve as the “gatekeeper” for all essential documents which require signatures in the Columbus region; disperse documents, submit signed copies to the requestor, hold wet-inks, mail originals when requested, and track appropriately

Other duties and responsibilities as assigned

Minimum Position Requirements:

Education: Appropriate education and/or experience may be substituted on equivalent basis

Required: HS/GED

Preferred: Bachelor’s Degree in related field

Experience:

Preferred: 1 year or more of professional experience

Knowledge, Skills, & Abilities:

Ability to maintain professionalism and professional standards. Must have a sense of urgency. Set priorities. Identify and resolve problems effectively and efficiently. Excellent communication and organizational skills for managing workflow and follow-up. Ability to demonstrate reliability and maintain confidentiality. Must have a “do-what-it-takes” attitude. Excellent speaking skills to communicate clearly and effectively with patients, physicians, industry professionals, and others in person or over the phone.

Background Checks:

Background and criminal history check

Drug Screen

Others as needed

Physical Demands:

Manual Dexterity: Work requires moderate speed and accuracy, excellent keyboarding skill for computer use.

Physical Effort: Work requires considerable variety of fairly steady active physical exertion. Some and/or continuous standing or walking. Some lifting of items less than 20 lbs.

Working Conditions: Potential for early morning and/or late-night responsibility