Collette Marietta

About Collette Marietta

Over 28 years of experience as a Clinical Site Manager or Senior Clinical Research Associate working with Contract Research Organizations (CROs), Pharmaceutical, Biotechnology, and Medical Device companies on Phase I-IV clinical trials. Monitor responsibilities include: Identifying Sites, Site Qualification, Initiation, Interim Monitoring, blinded/unblinded Drug Accountability, and study Close-Out visits. Familiar working with both CRO and Sponsor SOP’s and strictly adhering to the protocol, Manual of Operations, GCP/ICH Guidelines, Code of Federal Regulations (CFR) and ISO14155 and all applicable federal regulations. Worked closely with sites to provide training and ensure all staff are qualified and have a solid understanding of the protocol and logistics of the study requirements. Provide help and guidance to site staff regarding resolution of action items and training as required. Understand importance of identifying site issues, communicating with the study team and escalating issues as needed. Prepares, submits, and finalizes site visit reports within study required timeframes. Reconciles Investigator Site File/Regulatory Requirements with Trial Master File. Knowledgeable in overseeing randomization, dose/treatment and procedures in a blinded and unblinded manner. Prepares, submits, and finalizes site visit reports within study required timeframes. Completes and remains current with all sponsor and CRO required SOP trainings. Therapeutics areas include: Cardiovascular, Dermatology (Psoriasis), Device, Diabetes, Gastroenterology (GERD), Neurology (MS, Epilepsy, Alzheimer’s), Oncology (Prostate Cancer), Orthopedic (Lumbar and Cervical Spine, Knee and Plantar Fasciitis), Pain, Psychiatry (Schizophrenia, Depression), and Women’s Health.

Experience

1. Senior Clinical Research Associate

   Medtronic

   Oct 2023 — Present

Education

• Missouri Southern State University

  Bachelor's Degree, Business Administration and Management, General

  1983 — 1986

• University of Mississippi

  BS, Business Administration

  1981 — 1982