Senior Regulatory Specialist

2 weeks ago

Houston, Texas, United States DM Clinical Research Full time

Senior Clinical Research Regulatory Specialist (Remote)
 
The Senior Clinical Research Regulatory Specialist works closely with our Clinical Research staff to provide excellent regulatory oversight for our clinical trials under the supervision of the Regulatory Manager.

DUTIES & RESPONSIBILITIES
  • Prepare, facilitate, and coordinate 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
  • Ensure that all documents are complete, and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB
  • Follow-up, communicate and facilitate responses to queries of the IRB, Sponsor and other committees as a result of their review of submissions
  • Coordinate the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research
  • Obtain Sponsor approval of consent form prior to submission to the IRB
  • Facilitate and coordinate the timely and accurate submission of regulatory documents (such as but not limited to: FDA form 1572, protocol signature page, delegation of authority logs, etc) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents
  • Create and maintain regulatory documents in collaboration with the clinical site
  • Ensure that regulatory ISF binders are audited and maintained routinely
  • Track workload and status of pending protocols and associated supporting documents 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
  • Provide training and supervision on assigned regulatory staff members
  • Any other matters as assigned by management
 
KNOWLEDGE & EXPERIENCE

Education:
  • Associates degree required
  • Bachelor's degree preferred 
Experience:
  • 2+  years of clinical research coordinator experience or 3+ years of clinical regulatory experience (or equivalent)
Credentials:
  • N/A
Knowledge and Skills:
  • 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 to meet deadlines.
  • Strong ability to establish and maintain effective working relationships. 
  • All employees of DM Clinical Research, In any capacity, are expected to:
  • Always treat others with dignity and respect
  • Always conduct themselves in an ethical manner
  • Comply with all local, state, and Federal, including FDA, regulations pertaining to the conduct of clinical trials on human subjects
  • Comply with departmental and company expectations, policies, and procedures at all times
  • Report to work as scheduled and seek approval from your supervisor in advance for any changes to the established work schedule, including the use of leave and late or early arrival and departures.
  • Perform assigned duties and responsibilities with the highest degree of trust.
  • Protect patient privacy at all times by keeping discussion of names and medical conditions confined to private locations, out of earshot of anyone not employed by DMCR.
  • Be polite, upbeat, and professional, on the phone and in person.
  • Maintain a high level of professionalism with CRAs and any Sponsor or CRO employee or representative

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