Job Overview:
The Regulatory Coordinator will manage all aspects of study start-up including but not limited to, Contracts, Budgets, IRB Submission, Site Qualification Visits, SIV required documents, and any other regulatory needs. After start up is complete, the regulatory coordinator will be responsible for ongoing oversight of protocol amendments, ICF Version updates, annual reporting, study close-out and submissions to the Institutional Review Board (IRB), any relevant regulatory agencies and the clinical trial sponsor for all active studies at our site. The Regulatory Coordinator is responsible for ensuring all required documentation is initiated and maintained completely, accurately, and in a timely manner. Applicant must have the ability to work proactively and independently in a fast-paced environment and to prioritize and manage the workflow of multiple projects. Demonstrated attention to detail, ability to meet tight deadlines, professional initiative, teamwork, and reliability is expected. Must be able to work diplomatically and professionally with administration, faculty, and clinical personnel. Ability to simplify and distill complex concepts into clear and concise language and possess strong problem-solving capabilities.
Our ideal candidate will have experience with contracting and budgeting and an understanding of regulatory compliance in relation to clinical research trials.
We will require this individual to be in the office most of the week with the ability to work remotely on Wednesdays.
Duties:
- Manages regulatory activities for all stages of clinical trials and submits regulatory documents to Sponsor and IRB and works with clinical research team to ensure submission documents are up-to-date.
- Prepares, submits, tracks, and responds to all regulatory (FDA and IRB) requirements,
- Prepares and submits progress reports and renewals to the IRB and sponsors.
- Responsible for ensuring that all regulatory documents are created, signed and filed in their appropriate location.
- Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. Provides guidance to research staff to ensure compliance with rules and regulations associated with clinical research studies.
- Completes industry registrations and study feasibility questionnaires including receipt, tracking and correspondence with Sponsor/CRO/ARO
- Prepare and submit start-up regulatory packets to Sponsor and IRB
- Oversee study start-up activities to include reporting and communicating with stakeholders on a regular basis.
- Serve as a liaison to Sponsors/CRO/IRB/Investigators assuring continuity of service and problem resolution.
- Monitor approval status of open studies by completing timely reviews.
- Maintain master files of all regulatory-related documents.
- Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits.
- Creation of study source documents for all new trials.
- Will be responsible for invoicing sponsors to ensure proper payment for trials related activities.
- Assist during monitoring visits regarding regulatory compliance.
- Will need to assist with recruitment efforts.
Skills:
- Strong knowledge of compliance management and FDA regulations
- Experience in conducting clinical trials and managing all aspects of the process
- Proficiency in data collection, analysis, and interpretation
- Excellent organizational skills with the ability to manage multiple projects simultaneously
- Strong attention to detail and accuracy in data management
- Effective communication skills to collaborate with cross-functional teams
- Ability to analyze complex information and make informed decisions based on research findings
- Proficiency in using relevant software applications for data analysis
If you are a dedicated, experience and have a passion for advancing healthcare through clinical research, we invite you to apply for this position. Join our team and contribute to groundbreaking discoveries that will shape the future of medicine.
Job Type: Full-time
Pay: $28.85 - $30.00 per hour
Ability to Commute:
- Santa Fe, NM 87505 (Required)
Work Location: In person