Clinical Research Specialist

Job Description

70% of an average work week, so about 28 hours/week.

Preferably working from New Haven, CT.

Contractor will need to train onsite and then be able to work remote

Job description:

• Provide product training and support to clinical sites for the pill cam procedure.
  
• Support the randomization process and act as the IWRS PRIMARY Administrator
• Arranging and participating in the organization of study team meetings Taking minutes and distributing
• Managing and maintaining study documents and trial supplies, colonoscopy forceps, FedEx envelop, IWRS User information.
• Administer, Maintain and coordinate the logistic aspects of clinical trials according to GCP and Sop’s
• Ensure That any clinical trial databases/tracking tools are set up and maintained throughout the trial
• Assist with collating, tracking & shipping CRFs & Data queries to data management
• Maintaining study data control table
• Review and approve monitoring reports in Siebel
• CTM SW update
• Coordinating archiving of study documentation
• Perform and support study site qualification, Initiation interim monitoring and closeout visits according to SOP’s GCP’s, FDA regulation and ICH guidelines at multiple investigational sites
• Ensure safety and welfare of Patient enrolled in clinical study
• Site management to ensure Compliance
• Ensure integrity of data reported
• Helping in setting up the Study centers, Which includes ensuring each center has the trial materials and training site staff to trial-specific standards
• Administrative support for CA and date management team including: shipment training records and inventory control.

Qualifications

Bachelor’s degree Engineering/ (B.A./B.S.C./Other)

Experience required:

0-2 years

Additional Information

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus

Thank you for your time and consideration. I look forward to hearing from you!

Warm Regards,

Nisha

Integrated Resources, Inc.

IT REHAB CLINICAL NURSING

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 ,2013 and 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

Direct: (732)-429-1649

Tel: (732) 549 2030 x 230

Fax: (732) 549 5549