Erik Gamelson Email & Phone Number

Cary, North Carolina, United States

Clinical Trial Manager

Cary, North Carolina, United States

Carlsbad, California

Home-Based

My responsibility was to liaise with study sites regarding essential document collection and to assist with IRB/EC submissions. I managed over 1,000 sites for IRB continuing review approval utilizing multi-functional teams to ensure timelines were met. In addition, I was specifically responsible for the management of multiple studies in the maintenance phase of the clinical trial process. I completed review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process. I was responsible to customize country/site specific Patient Information Sheet and Informed Consent Forms and to review updated study documents. I arranged and reviewed translations of relevant study documents. I provided regular local status updates to SSU Project Lead; updated appropriate study-tracking tools with local essential document and ethics committee status, and maintained project tracking systems for assigned projects

La Jolla, California

Provided cross-functional clerical and administrative support to EDCS Team. Maintained EDCS-specific tracking reports (e.g. CRT tracking). Completed 2nd review support for EDC documents submitted from Country Submission Specialists for international trial sites. Performed QC checks to SOP standards and submitted regulatory and administrative documents for the Trial Master File (TMF). Trained Clinical Trial Assistants on job functions.

Managed Design History File (DHF) and phase gate deliverables. Performed review audits of DHF, verification of DMR outputs, document remediation and compliance. Assisted with Project Management activities.

Managed and executed an FDA required 8 month study including writing multiple interim reports, performing sophisticated data analysis, managing multiple technicians, and projecting timelines. Responsible to assist research scientists with R&D activities.

Greater San Diego Area

Contracted through Aerotek Scientific. Test medical diagnostic medical devices pipetting blood and other fluid samples using various SOP's and GMP's. Batch, TTR, and Flow timing testing.

Wichita, Kansas Area

Responsible to assist in the operating room moving patients, holding arthroscopes and generally assisting the Physician and Physician Assistant. Clinically responsible to take medical histories and help examine patients.

Riverside, Ca Area

40 hour didactic and practical education30 hour clinical externship at Riverside County Regional Medical CenterResponsible for obtaining blood from patients and labeling the collection tubes properly. Used vacutainer and winged infusion set for blood collection

Bachelor Of Science (B.S.), Biological Sciences

Activities and Societies: Cornerstone Bible Fellowship Leadership Team 2009-2010

Certified, Industrial Biotechnology

Through the EDGE initiative and BIOCOM Institute, I completed an online Industrial Biotechnology Immersion program which focused.

Phlebotomy Certification, Phlebotomy

30 Hour Phlebotomy Externship at Riverside County Regional Medical Center