Clinical Research Regulatory Specialist

Clinical Research Regulatory Specialist

Department
Tomball
Employment Type
Full-Time
Minimum Experience
Experienced

DM Clinical Research, the largest privately-owned research management organization in the Houston area and one of the top 50 in the country, is looking for a Clinical Research Regulatory Specialist. This position works closely with our Clinical Research staff to provide excellent regulatory oversight for our clinical trials.

Responsibilities

• Prepares, facilitates and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy.
• Ensures that all documents are complete and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB. Follows-up, communicates and facilitates responses to queries of the IRB, Sponsor and other committees as a result of their review of submissions.
• Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state and local agencies governing biomedical research.
• Obtains Sponsor approval of consent form prior to submission to the IRB. Facilitates and coordinates the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents.
• Ensures that regulatory binders are audited and maintained. Tracks workload and status of pending protocols and associated supporting documents in order to provide efficient customer service to the Research team.
• Participates in quality assurance (QA) and control programs related to overall project and patient data, as needed.
• Oversees QA initiatives for the department to support research staff and leaders during sponsor and FDA audits

Requirements

• Have at least one year of experience as a CRC,
• Strong written and oral communication skills.
• Proven leadership skills in project management, including project management tools and techniques.
• Strong computer skills, including Microsoft Office, Excel and PowerPoint.
• Ability to manage time sensitive projects in order to meet deadlines.
• Strong ability to establish and maintain effective working relationships.

Job Type: Full-time