BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Clinical Trial Associate to work for a leading San Diego biotechnology company.
Clinical Trial Associate
Local San Diego candidates only, please
IVD or Device Experience required
Assist in all clinical team activities for start-up, oversight, and study closure to include coordinating the preparation and assembly of clinical trial supplies and materials for distribution to clinical sites with minimal/moderate supervision. Maintain related tracking information of all clinical materials, shipments, and inventory. Assist the Data Management team in tracking and management of Case Report Forms (CRFs) and Laboratory Submission Forms (LSFs). Assist in maintaining files and tracking of all written and electronic documentation for all study records and site interactions in the Trial Master File (TMF). Communicate with sites regarding query resolution to ensure compliance with specified protocols and accuracy of submitted data. Participate in data entry, data auditing, clinical site queries and overall clinical data flow from multiple clinical sites in a timely and professional manner. Coordinate in-house specimen procurement studies. Willingness and ability to learn, understand and apply regulatory guidelines and Good Clinical Practices (GCPâ€™s) applicable to IVD and Medical Devices for conducting clinical field trials, CLIA Waiver and 510(k) submission studies. Be familiar with GCP, FDA regulations and relevant Standard Operating Procedures for clinical research. Develop skill and knowledge with regulatory procedures and become familiar with product development procedures. Interact with study coordinators and in-house study participants.
Assist with data entry as necessary, and audit field clinical trial data for inclusion in regulatory submissions. Help implement and maintain clinical trial tracking databases for each clinical study. Responsible for maintaining Trial Master Files for all clinical studies.
Works closely with the clinical team to provide clinical support. May assist in the conduct of readability studies to validate ease-of-use of test materials and reliability of draft procedures.
Assemble and ship IUO kits and supplies for clinical studies. May help clinical team identify clinical trial sites. Assists in the preparation for initiation of clinical studies and monitors and tracks the progress of those studies via in-house oversight.
Supports obtaining IRB study approvals through direct communication with clinical sites enabling acquisition of required regulatory submission documents.
Recruit subjects for in-house specimen acquisition and maintains necessary supplies for specimen acquisition in support of development needs.
Carries out duties in compliance with established business policies.
Education and Experience:
Requires a BS/BA in any biological science or Medical Technologist degree (or equivalent combination education and/or work experience) with a minimal of 1-2 years progressive clinical research experience. Previous research or scientific technical experience in the IVD, medical device or bio/pharma industry preferred. Prior experience or certification in clinical trial design, Clinical Research Coordinator (i.e. CCRC), and/or data management experience highly desirable. Required experience with TMF/clinical study file documentation oversight and Quality Control, Good Clinical Practice, Good Documentation Practice, and strong understanding of the impact of the TMF on Trial Management.
Knowledge of medical terminology and good clinical practice required. Detail-oriented with a high level of organizational skills; good written and verbal communication skills; excellent interpersonal skills, maintains professionalism at all times, with ability to resolve conflict. Advanced computer skills (Word, Excel, Outlook, Access) or equivalent required.
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. The goal of BioPhase is to...