Clinical Research Associate (Contract)

POSITION SUMMARY

 

This position assists clinical project manager and Clinical Research Team (CRT) in the management and coordination of assigned clinical research studies, in compliance with FDA regulations, ICH GCP guidelines, and SOPs to ensure that project goals are met.  The candidate will work under general supervision with detailed instructions on new assignments

 

ESSENTIAL DUTIES & RESPONSIBILITIES

 

·  May serve as a liaison with CROs to ensure quality service and clinical study conduct.

·  Evaluates and participates in selection of consultants, CROs, and study sites to conduct clinical research activities.

·  Ensures that the clinical study sites, CROs, and other vendors are in compliance with GCPs and relevant SOPs.

·  Tracks activities associated with clinical trials.

·  Co-ordinates and participates in Clinical Research meetings

·  Under direction of a clinical project manager, prepares necessary clinical documents and study-related documents, such as assigned portions of a protocol, protocol amendments, informed consent guidelines, assigned portions of investigator brochures, transfer of regulatory obligations forms, and study operations manuals.

·  May assist in preparing and reviewing Statements of Work (SOWs) and Requests for Proposals (RFPs).

·  Provides direction to CRO Clinical Research Associates.

·  May perform clinical site visits.

·  May provide support during regulatory agency inspections.

·  Performs other duties as assigned.

·  Has primary responsibility for collection of essential regulatory and other study-specific documentation related to assigned projects.

·  Participates in the review of Investigator Brochures, study reports, safety reports, statistical tables and data listings, and clinical sections of Annual Reports, INDs, marketing applications (NDAs), and briefing documents.

·  Work with internal staff, consultants and medical writers.

 

QUALIFICATIONS

 

·  Minimum of 3 or more years experience in clinical research and project management with at least 1 year of clinical monitoring (CRA) and/or site management experience.

·  Training and appropriate knowledge of GCPs and regulations.

·  Ability to interact with vendors and subcontractors to successfully meet and/or exceed timelines and goals.

·  Ability to maintain current with, and proficiency in, applicable FDA regulations and guidelines.

·  Experience with setting up, managing and maintaining filing systems in support of clinical research studies.

·  Demonstrates excellent time management and organizational skills to meet multiple deadlines.

·  Excellent verbal and written communication skills and interpersonal skills.

·  Working knowledge and proficiency in various computer applications including MS Office (MS Word, Excel, PowerPoint).


REQUIRED EDUCATION / CERTIFICATIONS / LICENSES

 

·  Bachelor’s degree in science related field (BS, BA, RN).

·  Advanced degree preferred.

 

ADDITIONAL INFORMATION

 

·  Required to work from corporate office in Aliso Viejo, CA.

·  Travel up to 30% may be required.

·  Flexible work hours to meet department deadlines.