Clinical Research Coordinator - Open Rank

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When you join the UMass Chan Medical School team, you join us in advancing together to improve the health and well-being of our diverse communities throughout Massachusetts and across the US and the world.Together, we lead in education, research, health care delivery, and public service. Your life’s work is more than a career. It’s an expression of your passion, intellect, skill, and drive.UMass Chan's commitment to excellence, innovation, competitive benefits, and work-life integration will allow you to build a professionally rewarding career as we work together to better or improve the health of people around the globe.

POSITION SUMMARY:

Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator 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 research protocols related to treatment, ancillary services, and prevention practices.

This is an open-rank posting (there are 4 levels of Clinical Research Coordinator) - candidates will be hired into the level commensurate with their experience.

ESSENTIAL FUNCTIONS:

Clinical Research Coord I:

• 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
• Maintain all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors
• Identify issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance
• Document and collect data and/or samples for research related procedures performed during participant study visits.
• Ensure clinicians and/or PI accurately document their study activities according to protocol
• Track and maintain study enrollment and completion of milestones
• Assist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe.
• Track and maintain study related information in the data management system within the required timeframe
• Responsible for monitoring the inventory of research related supplies
• Participate in grant preparation, manuscript writing, data presentations and Institutional Review Board (IRB) processes
• Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs
• Present study status reports related to assigned research projects
• Participate in the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Maintain strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines.
• Comply with all safety and infection control standards appropriate to this position
• Adhere with established policies, health and safety regulations and requirements, procedures, and department objectives
• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices
• Must practice discretion and adhere to school and hospital confidentiality at all times
• Perform other duties as required.

Clinical Research Coord II

Duties noted above plus:

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

Clinical Research Coord III

Duties noted above plus:

• Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocols
• 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

Sr Clinical Research Coord

Duties noted above plus:

• Responsible for internal review/monitoring of clinical data for quality assurance purposes. Reports findings
• Responsible for the smooth operation of all assigned studies on a day-to-day basis, interacting with investigators, staff members, clinicians, sponsors, etc. to ensure project timelines and goals are met
• Contribute independently to the development of preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• May Supervise the activities of research support staff. Assist with the selection, training, and supervision of staff
• Prepare ongoing summary reports from various data sources, and collaborate with investigators on data presentation, interpretation, and the writing of manuscripts for publication and grant proposals
• Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance
• Accountable for quality assurance reviews of study data
• Assist with financial /operational aspects of grant and contracts. Responsible for clinical research billing review within the required timeframe.
• Contribute independently to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processes

REQUIRED QUALIFICATIONS:

Clinical Research Coord I:

• Bachelors degree in a scientific or health related field, or equivalent experience
• 0-1 year of related experience
• Ability to travel off site locations

Clinical Research Coord II:

• Requirements noted for CRC I plus:
• 1-3 years of related experience

Clinical Research Coord III:

• Requirements noted for CRC I plus:
• 3-5 years of related experience

Sr Clinical Research Coord:

• Requirements noted for CRC I plus:
• 5-7 years of related experience
• Demonstrated knowledge of quality management principles in a scientific or hospital setting

This position will provide day-to-day oversight and coordination of the WASLI initiative in partnership with the ATTC National Coordinating Office (NCO) and the broader New England ATTC team as needed, ensuring successful implementation of the curriculum, leadership activities, participant engagement, and program evaluation. He will manage regional recruitment, onboarding, communications, logistics, and ongoing support for regional participants, coaches, and mentors, while also overseeing regional project activities, including travel coordination, leadership project monitoring, and reporting requirements. In addition, project staff will support the WASLI mentor through regular coordination, scheduling, resource sharing, and communication to ensure alignment with program goals and successful delivery of mentorship, coaching, and leadership development activities for participants.

Posting Disclaimer:

This job posting outlines the primary responsibilities and qualifications for the role but is not intended to be an exhaustive list.Duties and expectations may evolve in response to the needs of the department and the broader institution.

In alignment with our commitment to pay transparency, the base salary range for this position is listed above (exclusive of benefits and retirement).At UMass Chan Medical School, final base salary offers are determined based on a combination of factors, including your skills, education, and relevant experience.We also consider internal equity to ensure fair and consistent compensation across our teams.

Please note that the range provided reflects the full base salary range for this position. Offers are typically made within the midrange to allow for future growth and development within the role.

In addition to base pay, UMass Chan offers a comprehensive Total Rewards package, which includes paid time off, medical, dental, and vision coverage, and participation in a 401(a)-retirement plan, with the option to contribute to a voluntary 403(b) plan.

UMass Chan welcomes all qualified applicants and complies with all state and federal anti-discrimination laws.