Location:

Pay Range:

Position Summary

Research Regulatory Coordinator is responsible for collaborating with the PI’s and internal and external members of the clinical research team within scope of clinical trial regulatory submission and compliance. Assist in preparing regulatory submissions and maintaining the regulatory files. Coordinate the preparation of regulatory documents for submission to the Institutional Review Board (IRB) or other IRB’s as determined, other internal committees and the FDA as necessary including but not limited to: Initial documents submission; Continuing Reports; Amendments and addendums to research protocols and consent documents and Adverse Event reporting. Collaborate with study team members to perform these duties. Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations.

Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.

Primary Key Performance Areas

KPA 1 – Creates and maintains central regulatory files in accordance with site SOP.

• Adhere to and maintain working knowledge of practice policies, the Federal regulations, ICH, and GCP guidelines.

• In compliance with the Code of Federal Regulations under the Health Insurance Portability and Accountability Act (HIPAA), assure that patient records will be kept confidential and secure.

• Maintain the investigative site study files and regulatory binders.

• Responsible for the preparation of archiving closed studies for long-term storage

• Collect and maintain study specific documentation (for main and satellite locations as needed) in the appropriate Regulatory Binder as well as the electronic document system including:

  • Create and maintain the Research Delegation of Authority logs and role specific profiles, ensure revised profiles to investigators and research staff as roles and responsibilities necessitate.

  • Create and maintain study-specific FDA Form 1572, ensure form is reconciled and updated as change necessitates.

  • Collect and maintain Financial Disclosure Forms as completed by investigators, escalate reported disclosures to leadership if reported.

  • In collaboration with various departments, maintain historical credentials all current and previous Investigators and research staff, laboratory licenses, CLIA/COLA. Produce as needed for Sponsor/CRO review.

• Maintain credible documentation by using ALCOAC method (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).

• Support GCP and protocol specific training for staff and investigators by:

  • Upload and archive protocol specific training modules for all studies.

  • According to site SOP, distribute training module assignments and maintain documentation GCP training for all research staff and investigators.

KPA 2 – Ensure completion, submission and subsequent distribution of IRB approved documents in accordance with site SOP.

• Process regulatory documents: initial submission, ongoing required documents for each study, continuing review, study closure procedures in accordance with GCP, ICH/FDA requirements.

• Process IND safety reports.

• Prepare and ensure timely reporting and submissions to IRB in accordance to site SOP and federal regulations including:

  • Initial IRB submission and approval is obtained at study activation and maintained in the Regulatory Binder

  • Obtain documentation of IRB approvals, including amendments and revision to study related documents, such as revised informed consents and protocols and maintain in the Regulatory Binder.

  • Complete the IRB Continuing review reports required by the IRB and submit to the applicable IRB. File all correspondence regarding continuing review report submission in the Regulatory Binder.

  • Ensure the process is followed for reporting any Serious Adverse Event (SAE) to the IRB that meets IRB reporting guidelines, as determined by the PI.

• Notify the Research Coordinators and applicable investigators via email when a new/amended Protocol or ICF has been IRB approved.

  • Ensure research coordinators are provided IRB instructions for reconsenting subjects in timely manner.

  • Review signed ICFs for completeness and notify the Research Coordinator of any discrepancies

  • Maintain internal log of consent versions

• Maintain a master subject/enrollment list electronically for each study until the study is terminated and records are ready to archive

KPA 3 – Effectively manage monitoring and audit activities according to site SOP

• Support on-site and remote monitoring activities through:

  • Scheduling and preparing for interim monitoring visits (IMV) by ensuring the Regulatory Binder is complete prior to IMV. When discrepancies are noted during the monitoring visit, work collaboratively with the research coordinator to ensure any noted discrepancies are corrected. Request that the monitor summarize any findings, issues or concerns during the visit in a follow-up letter and note status of resolution.

  • Meet with the Sponsor representative as needed during visits to ensure issues are resolved appropriately and in a timely manner.

  • Maintain the Site Visit Log and ensure monitors complete the log prior to departure.

  • Following the IMV, review monitor report/letters and forward to appropriate staff for review. Ensure all identified issues are addressed prior to the next monitoring visit. Maintain a copy of the letters in the Regulatory Binder

  • Complete daily communication with the Sponsor/CRO and responds within a timely manner

• Termination and Closeout activities

  • Work with monitor to schedule, prepare, and conduct the Study Termination Visit.

  • Prior to scheduled Study Termination Visit, ensure all study documents are filed and any discrepancies are addressed in a NTF. Send required documents to Sarah Cannon and ensure all electronic documents and reporting systems are final signed.

  • After study closure and all queries have been resolved, ensure files are packaged and archived

• Prepare for internal and external audits by retrieving all documents and ensuring all study related documents are complete prior to the audit.

• Performs other duties and projects as assigned.

Position Qualifications/Requirements

Education

• High school education required

• Bachelors’ degree in Biological Science, Social Sciences, English, or other related field preferred

Certifications/Licenses

• Valid state Driver’s License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.

Previous Experience

• Prior clinical research experience is preferred but not required.

Core Capabilities

• Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.

• Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.

• Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.

• Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.

• Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.

• Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.

• Computer Skills:

  • Proficiency in MS Office Word, Excel, Power Point, and Outlook expected.

Travel: 0%

Standard Core Workdays/Hours: Monday to Friday 8:00 AM – 5:00 PM.

#LI-REMOTE