Regulatory Analyst Jobs

Position Overview:

Under the supervision of the Director of Clinical Research, The Regulatory Analyst completes and maintains regulatory documents for clinical research projects to ensure compliance with the study protocol, established institutional policies and procedures, applicable regulations and Good Clinical Practice (GCP) Guidelines.

The position will manage all aspects of day-to-day regulatory operations and supporting clinical research regulatory matters as follows: study intake and feasibility assessment facilitation, start-up, Institutional Review Board (IRB) / Sponsor submissions, modification submissions, continuous reporting, study close-out; financial support; communicate with internal and external stakeholders; and any relevant regulatory agencies. This position will be responsible for managing all central documents, e.g., credentials & training files for all study staff; lab documents; and IRB manuals, forms and documents. The Clinical Research Regulatory Analyst will perform administrative duties as needed and is responsible for performing job duties in accordance with the mission, vision and values of client.

DISCLAIMER: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this intends to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks performed as assigned.

Education:

Associate’s degree in business, scientific or health related field or other related field required, bachelor's degree preferred. Will consider 3-5 years’ experience in lieu of education.

Certification:

Clinical research related certification strongly preferred or willing to become certified (e.g., Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Regulatory Affairs Certification (RAC)).

Experience:

• Has documented knowledge of and follows International Council on Harmonisation (ICH) Good Clinical Practice (GCP), Food and Drug Administration (FDA), Office of Human Research Protections (OHRP) and Health Insurance Portability and Accountability Act (HIPAA) policies & regulations, and federal, state and local rules and regulations.
• Two (2) years of clinical research regulatory, professional or related experience, one (1) year if bachelor’s degree.

Physical Demands:

The work will take you from the lab to the office to the board room.

Mental Demands:

Must demonstrate the ability to meet deadlines.

Special Demands:

Requires effective communication and time management skills. Requires ability to understand and conduct all regulatory aspects of a research study. Must be a self?motivated individual with the ability to think critically and work independently. Must be proficient with Windows-style applications and keyboard.

Selling Points

• Small Team
• Start up and ability to grow

3-5 Must Have Skills/Qualifications

• 2 Years of Regulatory Experience

Nice to Have Skills

• CTEP / CTSU / NCI CIRB experience would be very helpful

Schedule/Shift

M-F 8am-5pm