Clinical Project Manager or Senior Clinical Research Associate
| How to Apply for this Job |
Company: ThinkCentric
Contact Name: Donna Steiner
- Email your resume (Click Here)
Use one of the above methods to apply for this job.
|
- Job ID:
- Date:06/09/2008
- Location:New Jersey
- State:Not Listed
- Degree:B.S./B.A.
- Current Professional Level:Sr. Manager/Manager
- Salary:Not Specified Why?
- Job Types:
-
CLINICAL AFFAIRS, CRO Management, RESEARCH & DEVELOPMENT (Drug)
Job Description
Main responsibility will be to manage clinical trials of company’s lead products. Key responsibilities will include: active management of CRO's and other Clinical vendors; coordinating, preparing and compiling (primarily through a CRO) informed consent forms, study instructions, case report forms (CRFs), clinical monitoring plans and project plans; contributing to creation and review of protocols, informed consents, case report forms, clinical study materials and monitoring tools; interacting with multiple groups to drive RFP process and coordinate vendor selection; reviewing monitoring reports, studying invoices (Vendor, Site, CRO), tracking study progress, providing updates to management and maintaining study files; tracking (via a CRO) the investigational sites compliance with internal procedures and appropriate regulatory agency guidelines. This position may require up to 25% travel time. The ideal candidate will have a Bachelors degree in a life science or nursing, or be a Registered Nurse with equivalent experience, with a minimum 4-6 years experience in clinical development with at least 1 year in a study management role, expert knowledge of GCP's, ICH guidelines and FDA regulations, possess a professional demeanor and excellent communication skills. The successful candidate will be exceptionally detail-oriented, able to work independently and manage multiple priorities, and have excellent analytical and problem-solving skills. Oncology experience is highly desirable as well as a CCRA accredidation.
(3316)
