Clinical Research Coordinator (Site Lead / Founding Role)
Location: Central Florida (On-Site)
Specialties: Neurosurgery, Orthopedics, Pain Management, & Imaging
Employment Type: Full-Time
The Opportunity
We are an established, high-volume multi-specialty surgical and diagnostic practice (MRI, Neurosurgery, Orthopedics, and Pain Management) launching a dedicated Clinical Research Division. We are seeking a powerhouse Clinical Research Coordinator (CRC) to serve as our founding lead.
You will be the architect of our research infrastructure, working directly with our Board-Certified Physicians to transition our clinical excellence into a world-class investigative site.
Core Responsibilities
- Division Launch: Develop and implement Standard Operating Procedures (SOPs) for study conduct, drug/device storage, and data management.
- Study Startup: Lead the feasibility process, attend Site Selection Visits (SSVs), and manage the regulatory "green light" process (IRB submissions, 1572s, CVs, and Training Logs).
- Patient Management: Oversee the entire "subject" lifecycle, from pre-screening our existing patient database to Informed Consent, randomization, and follow-up visits.
- Sponsor Relations: Act as the primary point of contact for CROs and Sponsors; host Monitoring Visits (CRAs) and ensure 100% "inspection-ready" source documentation.
- Quality Assurance: Maintain ALCOA+ standards for all data entry in EDC systems and manage SAE (Serious Adverse Event) reporting with the Principal Investigator.
Qualifications & Requirements
- Experience: Minimum of 5+ years of active clinical research experience. Experience in Surgical, Orthopedic, Pain management or Device trials is highly preferred.
- Certification: CCRC (ACRP) or CCRA (SOCRA) certification is required.
- Technical Skills: Deep familiarity with GCP/ICH guidelines and experience with multiple EDC platforms (e.g., Medidata Rave, Veeva, Oracle).
- Leadership: Proven ability to work independently. You must be comfortable telling a Surgeon what they need to sign and when.
- Education: Bachelor’s degree in Life Sciences, RN, or equivalent clinical background.
Why Join Us?
- Build Your Legacy: You will have the autonomy to build this division your way, with full support from ownership and access to state-of-the-art MRI and surgical facilities.
- Competitive Compensation: Salary commensurate with experience.
- Growth: As the division grows, this role is positioned to evolve into a Director of Research position.
Background Screening (Florida): This position requires Level 2 screening through the Florida Care Provider Background Screening Clearinghouse. Learn more: https://info.flclearinghouse.com
