Job Description
Overview:
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.
This position is Hybrid
Field activities in the Worcester area for this position include:
Carry out field research activities for the Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study involving visits to Early Education and Care (EEC) centers in Worcester and surrounding areas. Activities at centers include CMV education, participant recruitment and enrollment, and bidirectional communications with families and staff members to enhance relationships. Requires engagement with children, families, and staff to offer study participation, complete the informed consent process and coordinate pediatric/adult sample collection (saliva, urine, blood) in compliance with all UMass Chan and EEC center policies. Some activities may include interfacing with community leaders and/or attending events in the Worcester area to increase CMV awareness and support building trust between the study team and community members.
Hybrid activities for this position include:
Attend study staff meetings and lab visits at the UMass Chan Medical School campus as needed. Work remotely on various study programs within the UMass Chan Medical School remote work policy.
Responsibilities:
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
- Coordinate participant remuneration/compensation per protocol
- 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
Qualifications:
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
University of Massachusetts Medical School
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