Regulatory is a department which falls under the Clinical Operations umbrella and functions collaboratively with clinical operations, medical and safety as support for study start-up, regulatory document maintenance, eTMF build and maintenance and closeout documentation such as IRB approval and study safety report distribution/IRB notifications. The Regulatory Lead (RL) manages the regulatory associates (RAI, RAII or RA III), guides the accumulation of regulatory documentation and prepares and/or reviews submissions for therapeutic, medical, or diagnostic device licenses to local or central IRBs, upload and in-process QC activities of the TMF/eTMF. The regulatory lead will be responsible and/or oversee the trial master file build (TMF), whether a paper-based or electronic format. The regulatory lead collects regulatory documents in an ongoing manner to maintain compliance with FDA, ICH, HIPAA, local, state or country laws and regulations. RA reviews, corrects with site, tracks activity and forwards regulatory documents to the sponsor. The RA interfaces with individual study sites to assure compliance with Good Clinical Practices (GCP), FDA and ICH and serves as an advisor on compliance difficulties. Participate in mentoring site and internal CRO staff regarding protocol and compliance issues. Maintain awareness of all FDA/GCP and ICH changes in regulations and forms. Interface with IRB, Sponsor, Study Coordinators, and Investigators to assure that compliance measures happen in accordance with regulations and in a timely manner. Bring regulatory concerns to the attention of the Regulatory Manager and Clinical Operations Lead and participate in finding solutions.
Education and Experience
Bachelor Degree (BA/BS) from four-year college or university or
Associate's degree (AA) or equivalent from two-year college or technical school
Five or more years related experience and/or training;
Equivalent combination of education, professional training and experience which provides the required knowledge, skills and abilities may be considered.
General experience is five to six years of progressively responsible experience, 2 years of which demonstrates the ability to:
Analyze problems to identify significant factors, gather pertinent data, and recognize solutions;
NCGS Incorporated, founded in 1984, is an international, full-service CRO that specializes in conducting and managing clinical trials.
NCGS’ mission is to protect research subjects, capture quality data and maintain integrity of the science with the same passion one would protect their own domain. Each staff member is charged to function under the mantra:
“these research individuals or subsequ...ent consumers could just as easily be your mother, your brother, your sister or yourself. The data NCGS collects will change healthcare for the future; believe in the impact we have on that process and appropriate characterization of the product. To be a part of the NCGS team, passion for our mission has to exist within each individual.”