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Senior Clinical Research Associate - (US-NC-NC)
Compensation: $50.00 - $60.00 / Hour
Minimum Education: Bachelors
Job Type: Full Time
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staffing@virtualresourcemgmt.com
Senior Clinical Research Associate – North Carolina - ENDOCRINOLOGY/DIABETES EXPERIENCE
Responsible for performing study site management activities regarding the implementation, monitoring, and summarization of clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Develop and maintain collaborative working relationships with clinical investigative sites. Reports to the Senior Regional Manager/Regional Manager, Field Trial Operations. Receives direction on individual clinical studies by the Site Management Lead, Project Manager and Clinician responsible for that project. Other internal relationships include other functional groups within CTO. External relationships are with clinical investigative sites.
* * Accountable for ensuing that sites meet the performance expectations with regards to recruitment, randomization and retention (planned vs. actual targets).
* Conducts on-site visits and on-site/off-site monitoring activities to ensure clinical investigative sites are complying with study protocols, FDA regulations, company SOPs, ICH Guidelines and GCPs including confirming patient eligibility, protocol compliance, tracking patient enrollment, reviewing informed consent forms, maintaining project and visit timelines, ensuring accurate transcription of data from source documentation to CRF/EDC and addressing data inconsistencies and clarification with the site staff and relevant NNI functional groups.
* * Ensure that mandatory entries for all business systems are in compliance with set department and trial goals (i.e. IMPACT, CATS, EDC, CSIIM, etc.).
* Utilize study tools and study/department websites as well as frequently updating required information on department websites.
KEY SUCCESS FACTORS
* BS degree (in science area) or registered nurse (4 year degree) with a minimum of four years of experience, or an MS degree with a minimum of four years experience. Previous clinical trial experience within industry or healthcare setting with a minimum of 4 years clinical monitoring experience required, Strongly prefer although not mandatory is diabetes therapeutic experience.
POSITION IS IN NORTH CAROLINA-SITE LOAD 8-10 SITES FOR AN ONGOING OBESITY TRIAL THAT IS IN MAINTENANCE PHASE. THERAPEAUTIC EXP. IN OBESITY AND OR DIABETES NEEDED.Glenn McClain
Virtual Resource Management Corporation
P.O. Box 598
Clarksburg, NJ 08510
Fax: 609-228-5002
Phone: 609-208-0333
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