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Reference Number:
BA_CRANYC
Job Description:
A Fortune 500 Pharmaceutical client of ours is looking for a Regional CRA based in New York City. Please send your resumes to badar@sunrisesys.com or call Badar Ansari at 732 603 2200 Ext 225 for further information.
Job Duties: Delivery of high quality data according to agreed time lines and budget, ensuring
adherence to international and local regulations and client's SOP standards.
Demonstrate exceptional customer focus as evidenced by positive feedback from 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 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 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:
Unspecified
Requirements:
Job Skills:
Basic medical and business knowledge.
Desired competency in clinical research or having demonstrated adequate level of proficiency within the CRA II competency profile.
Understands and can apply knowledge of clinical trial designs to trial execution.
Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
Expertise in communication, managing multiple priorities and computer literacy.
Education: A degree in a scientific or health care discipline preferred.
Eligible candidates may Email their resumes to Badar@sunrisesys.com or call Badar Ansari at 732 603 2200 Ext. 225 for more information on this job.
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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