Posted 3w ago

Clinical Research Coordinator-Founding Role

@ Direct Digital Holdings
Winter Park or Winter Park
OnsiteFull Time
Responsibilities:Division launch, Study startup, Patient management
Requirements Summary:5+ years active clinical research; surgical/orthopedic/pain or device trials preferred; CCRP/CCRA preferred; strong leadership and data management; EDC platforms experience; bachelor’s in life sciences.
Technical Tools Mentioned:GCP, ICH Guidelines, Medidata Rave, Veeva, Oracle
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Job Description


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