Remote Clinical Research Specialist

Integrated Resources, Inc. is a premier staffing firm recognized as one of the tri-state area's most well-respected professional specialty firms. Since its inception in 1996, IRI has built its reputation on excellent service and integrity. Our mission is to deliver high-quality talent, the first time and every time. We provide resources in four specialty areas:
Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.

Work Schedule: Approximately 28 hours per week (about 70% of a full-time schedule). Preferably based in New Haven, CT. The contractor will need to train onsite and then be able to work remotely.

• Provide product training and support to clinical sites for the pill cam procedure.
• Support the randomization process and act as the IWRS PRIMARY Administrator.
• Organize and participate in study team meetings; take minutes and distribute them.
• Manage and maintain study documents and trial supplies, including colonoscopy forceps, Fed Ex envelopes, and IWRS user information.
• Administer, maintain, and coordinate the logistical aspects of clinical trials according to GCP and SOPs.
• Ensure that clinical trial databases and tracking tools are set up and maintained throughout the trial.
• Assist with collating, tracking, and shipping CRFs and data queries to data management.
• Review and approve monitoring reports in Siebel.
• Update CTM software as needed.
• Coordinate archiving of study documentation.
• Perform and support study site qualification, initiation, interim monitoring, and closeout visits according to SOPs, GCPs, FDA regulations, and ICH guidelines at multiple investigational sites.
• Ensure the safety and welfare of patients enrolled in the clinical study.
• Manage sites to ensure compliance.
• Maintain the integrity of reported data.
• Assist in setting up study centers, ensuring each has the trial materials and trained staff to trial-specific standards.
• Provide administrative support for the clinical and data management teams, including shipment, training records, and inventory control.

Bachelor’s degree in Engineering, B.A., B.S.C., or other relevant fields.

Experience required: 0-2 years.

Feel free to forward this email to colleagues who might be interested. We offer a 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

Since 2007, 2008, 2009, 2010, 2011, 2012, 2013, and 2014 (8th Year)