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Reference Number:
BA_CRAMN
Job Description:
A leading Fortune 100 pharmaceutical client of ours has an opening for a Regional CRA based in Minneapolis, MN.
Job Description
Delivery of high quality data according to agreed time lines and budget, ensuring
adherence to international and local regulations and the client's SOP standards.
Demonstrate exceptional customer focus as evidenced by positive feedback from the client's colleagues and external customers (Investigators).
Participate in the site nomination process; perform evaluation of site capability to deliver the contractually agreed to number of patients and high quality data then make recommendation for inclusion in the clinical trial.
Assume ambassadorial role to facilitate communication between sites and the client's line functions to increase value proposition to investigators.
Facilitate preparation and collection of site level documents.
Execute site initiation and training activities.
Perform monitoring visits according to monitoring plan and author study monitoring reports.
Manage site drug supply management.
Resolve site level update of technical systems (ClinAdmin, EDC).
Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).
Manage recruitment implementing appropriate contingency plans as needed.
Assure continual GCP, ICH and the client's SOP compliance (Informed consent process, source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.).
Resolve deviations to standard by remedial action and training.
Perform data query resolution process (both at Site and with Data Management).
Execute site closeout activities.
May act as local (or global) CRA Lead, as assigned.
May act as a mentor to new associates for purposes of field training, as assigned.
Experience Level:
2 Years
Requirements:
Basic medical and business knowledge.
Manager would consider a strong coordinator
Must have home-based office and live near the sites to monitor.
1-3 years experience in clinical trials field monitoring required
Expertise in communication, managing multiple priorities and computer literacy.
Education: BA/BS or advanced degree
Interested candidate may send their resume in MS Word format to badar@sunrisesys.com or call Badar Ansari at 732 603 2200 Ext 225 for more details regarding this job opportunity.
Badar Ansari
Sunrise Systems,Inc.
New Jersey,USA
Phone 732 603 2200 Ext. 225
Fax 732 603 2208
Email : badar@sunrisesys.com
Web site : www.sunrisesys.com
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