Clinical Research Coordinator III

University of Massachusetts Medical School; Shrewsbury (MA); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

University of Massachusetts Medical School is seeking a Clinical Research Coordinator III to independently manage delegated tasks in human subject research, coordinating regulatory activities and data management for complex treatment and prevention protocols.

You will support investigators, sponsors, and auditors, manage study visits and regulatory documentation, and assist with grant preparation and protocol feasibility.

Formación

• Bachelor's degree in a scientific or health-related field or equivalent experience.
• 3–5 years of related experience.
• Ability to travel off-site locations.

Responsabilidades

• Obtain consent of participants under IRB protocols and HIPAA requirements.
• Assist with recruiting, screening, and maintaining study subjects for multiple protocols.
• Schedule and conduct participant visits, tests, and follow-up calls.
• Ensure accuracy of regulatory documents and data; support investigators and monitors.
• Direct activities of research support staff and assist with staff training.
• Develop study documentation such as questionnaires and data collection tools.
• Contribute to grant preparation, protocol feasibility, manuscript writing, and IRB processes.
• Monitor regulatory compliance and conduct QA reviews of study data.

Conocimientos

Regulatory coordination

Clinical data management

GCP compliance

IRB procedures

Educación

Bachelor's degree in science/health

Descripción del empleo

Overview

POSITION SUMMARY:

Under the general direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator III 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
• Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocols
• 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. Provide data/support to study Investigators, sponsors and/or external monitors/auditors
• Direct the activities of research support staff. Assist with the training of staff
• Develop preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processes
• Assist with financial /operational aspects of grant and contracts. Responsible for clinical research billing review within the required timeframe
• Conduct preliminary quality assurance reviews of study data
• Present study status reports related to assigned research projects
• 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
• 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
• 3-5 years of related experience
• Ability to travel off site locations