Senior Clinical Research Associate Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: Clinical/Regulatory
Collaborate with Clinical Manager and other project development team/department members on an ongoing basis throughout all stages of product development. Act in the role of core team member for assigned projects. Assist Clinical Manager in planning and organizing clinical study site start up procedures for all studies to include: contract & budget negotiation, submission of sponsor protocol documents to IRB, creating study training documents and ensuring shipping of study materials. Monitor clinical trials via on-site visits, telephone/email communication and in-house oversight. Travel to clinical trial sites for study initiation, interim monitoring, and study closure.
Assist Clinical Manager in the development and review of protocols, informed consents, CRF?s and any additional study documents as necessary. Must be able to perform site selection and conduct initiation visits including the training of site study personnel on study procedures and requirements. Able to set-up, oversee and monitor all aspects of clinical trials in all diagnostic areas assigned. Act as a liaison between study sites and Quidel team members. Responsible for the review and retrieval of required site regulatory documents to include the collection of CRFs, DRFs and other study specific documents. Actively participates in data management functions to include communication with clinical sites regarding query resolution, and auditing of data for accuracy of submitted data compared to recorded clinical database. Actively oversees analysis of data to include writing of final clinical study reports. Assist in Trial Master File (TMF) tracking of documents and materials. Identify external sources and oversee acquisition of specimens needed for product development. Assist with in-house specimen collection. Assist in writing protocols for external specimen collection if required. Maintain a high level of professional expertise through familiarity with clinical literature and current regulations.
Must understand and apply regulatory guidelines and GCP?s applicable to IVD and Medical Devices for conducting clinical field trials, CLIA waiver and 510k submission studies. Ensure compliance U.S. QSR and ISO9000 regulations, Good Clinical Practice, FDA regulations and relevant Standard Operating Procedures for clinical research.
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 minimum of 5+ years progressive clinical study research monitoring experience in the IVD, medical device industry required. Additional clinical monitoring experience in the bio/pharma industry highly desirable. Proven leadership role highly desirable. Certification in clinical trials design and management highly desirable. Prior data management experience and clinical study report writing skills highly desirable.
Strong knowledge of medical terminology and good clinical practice required. High level of organizational skills with a strong attention to detail required. Excellent interpersonal skills and professionalism at all times. Strong ability to mentor and utilize conflict-resolution skills required. Superior written and verbal communication skills required. Advanced computer skills (Word, Excel, Outlook, Access) and some statistical analysis experience required.
Quidel is proud to be an Equal Opportunity Employer / Affirmative Action employer M/F/D/V.
Location San Diego , CA
Minimum Experience (yrs):
Required Education: Not Specified
||San Diego, CA |
THIS JOB HAS EXPIRED