• Charleston, SC, USA
  • Full Time

Job Title: Regulatory Associate III

Department: Clinical Operations

Reports To: Regulatory Lead/eTMF Lead

FLSA Designation: Non-Exempt

Effective Date: 07OCT19

The Regulatory Associate III (RA III) guides the regulatory collection process, guides other associates in the accumulation of regulatory documentation and prepares and/or reviews submissions for therapeutic, medical, or diagnostic device licenses to local or central IRBs. The RA III collects regulatory documents in an ongoing manner to maintain compliance with FDA, ICH, HIPAA, local, state or country laws and regulations. RA III reviews, corrects with site, tracks activity and forwards regulatory documents to the sponsor. The RA III 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 agency and ICH changes in regulations and forms. Interface with IRB/EC, 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 Manager and participate in finding solutions. Performs ongoing QC of regulatory documents in the TMF/eTMF; reports quality performance metrics to project team. Works with Regulatory Lead and Regulatory Manager to measure performance of individuals and collective work teams, deploy interventions if required and to assist in the measurement the intervention outcome to resolve quality performance metrics.

Primary Responsibilities

  • Assists regulatory manager and clinical operations manager in coordinating efforts of regulatory associates
  • Works in partnership with clinical operations and any quality assurance initiatives in designing and enhancing quality management systems to facilitate overall Regulatory compliance.
  • Helps to establish and maintain policies and procedures to ensure compliance with government regulations and Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines.
  • Responsible for database tracking of study sites; Regulatory documents and status from site recruitment/ targeting to study close, including input for CTMS (Clinical Trial Management System) database design and management, query and report design.
  • Responsible for the distribution of Regulatory documents to the sites, including materials needed for IRB submission/approval, site activation, drug shipment, study completion, Investigational New Drug (IND) safety reports, Regulatory correspondence, correspondence from the Sponsor, protocol(s)/ amendments and Regulatory binders in accordance with the Code of Federal Regulations (CFR), NCGS Standard Operating Procedures (SOPs) and Sponsor guidelines.
  • Responsible for final review of Regulatory documents to ensure compliance with agency, Sponsor, and NCGS SOPs.
  • Responsible for tracking study site's IRB submission sites, IRB meeting dates, IRB approval status, IRB approval of protocols, Informed Consents, investigator brochures and IRB approval letter expiration dates.
  • Responsible for submission of Regulatory documents to Sponsor before activation, during the study and at study closeout.
  • Responsible for the dissemination of study sites' outstanding Regulatory documents to the NCGS Clinical team for the collection, and/ or for contacting the study sites to obtain outstanding Regulatory documents.
  • Acts as Regulatory liaison for medical or clinical research groups to keep Regulatory affairs department apprised of research progress.
  • Reviews Regulatory publications to keep apprised of new Regulatory developments. Communicates new developments to Manager of Regulatory Compliance.
  • Assist Central Files/eTMF and Project Coordinators as needed.
  • May provide QC checks of PC and/or eTMF staff work
  • Participates in conference calls and provide necessary Regulatory updates to Sponsor.
  • This job has minimal supervisory responsibilities.

Knowledge, Skills and Abilities

  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
  • Basic understanding of mathematical concepts.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software.

Education and Experience

  • Bachelor's Degree (BA/BS) from four-year college or university or Associate's degree (AA) or equivalent from two-year college or technical school;
  • Four or more years related experience and/or training; or equivalent combination of education and experience and certifications.
  • General experience is three to four or more 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;
  • Plan and organize work; and
  • Communicate effectively orally and in writing.
  • Experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower level of responsibility in the normal line of progression for the occupation in the organization or previous organization.
  • Consideration of applicant's total qualifying experience as a percentage of the experience required for the position combined with the applicant's education as a percentage of the education required for the position; and then adding the two percentages. The total percentages must equal at least 100 percent to qualify an applicant for this position.
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