Trace Brookins
Clinical Trials
- Role
- Vice President Operations at Opiaid
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Trace Brookins
Trace has been in the medical profession since 1983 with the past 30 years involved in the clinical trials industry. Progressive experience and industry knowledge has been gained by working in roles such as a CRA, Project Management and Quality Assurance for domestic and international pharmaceutical, biotechnology and medical device companies in both staff and consulting positions. He has conducted numerous Quality Assurance GxP, vendor and technology audits and established a Computer System Validation (CSV) program with an international technology vendor. Founded, operated and sold a successful CRO which was recognized by the international firm Deloitte and Touche. Also held senior roles in the establishment and growth of two oncology focused research companies. Trace is a co-founder of a technology company for remote clinical trials monitoring. A passion and desire to see technology play a more important role in clinical trials has afforded the opportunity to work with EDC and ePRO companies to help bring technology into the forefront of the industry. Continues to be an advocate for technology use in the clinical trials industry. Additionally, Trace owns The Anchor Bean Company a coffee roasting company.Specialties: Auditor: GCP, GLP, cGMP, Vendor Qualification, Computer System ValidationQuality: SOPs, Quality Manuals, CAPA implementationCRA: Pharmaceutical, Bioetech, Medical Device (I-IV, OTC)Technology: EDC, IVR, RDE, CTMS, RBM, SaMDStartupsBusiness DevelopmentOperations
Experience
Vice President Operations
Oct 2023 — Present
Skills
- Pharmaceutical Industry
- Fda
- Life Sciences
- Technology Transfer
- Ich-Gcp
- Business Development
- Pharmacovigilance
- Regulatory Submissions
- Leadership
- Start-Ups
- Project Management
- CRO
- Biotechnology
- Clinical Data Management
- Cross-Functional Team Leadership
- Computer System Validation
- Validation
- Quality Assurance
- Medical Devices
- Clinical Research
- Capa
- Clinical Development
- 21 Cfr Part 11
- Clinical Operations
- Clinical Trials
- Strategic Planning
- Drug Development
- Gcp
- Biopharmaceuticals
- Pharmaceutics
- Regulatory Affairs
- Lifesciences
- Edc
- Therapeutic Areas
- Standard Operating Procedure (Sop)
- Ctms
- Oncology
- Protocol
- Management
- Clinical Monitoring
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