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Clinical Research Coordinator II

  • Permanent
  • Anywhere

Website University of Massachusetts Medical School

University of Massachusetts Medical School

Company : University of Massachusetts Medical School

Country: United States

Location : Worcester, Massachusetts

Post: Sun, 31 Jul 2022 21:11:48 GMT

Expires: Sun, 28 Aug 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Overview:
POSITION SUMMARY:

Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator II is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for complex research protocols related to treatment, ancillary services, and prevention practices.

Responsibilities:
ESSENTIAL FUNCTIONS:

Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA

Identify, schedule and/or conduct participant study visits, tests and/or interviews/telephone follow up calls

Ensure accuracy and completion of all regulatory documentation, including local or central IRB and study data

Conduct preliminary quality assurance reviews of study data

Assist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe

Present study status reports related to assigned research projects

Contribute to data presentations and Institutional Review Board (IRB) processes

Track and maintain study related information in the data management system within the required timeframe Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs

Contribute to the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)

Responsible for monitoring the inventory of research related supplies

Document and collect data/ samples for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.

Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines. Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance

Comply with all safety and infection control standards appropriate to this position

Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices Perform other duties as required.

Qualifications:
REQUIRED QUALIFICATIONS:

Bachelor’s degree in a scientific or health related field, or equivalent experience

1-3 years of related experience

Ability to travel off site locations

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