Clinical Research Coordinator - Open Rank
Minimum Salary
US-MA-Worcester
Job Location
1 week ago (11 / 12 / 2025 4 : 23 PM)
Requisition Number
2025-48787
# of Openings
Posted Date
Day
Shift
Exempt
Exempt / Non-Exempt Status
Non Union Position -W60- Non Unit Professional
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.
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 dataContribute to data presentations and Institutional Review Board (IRB) processesTrack and maintain study related information in the data management system within the required timeframeContribute 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 complianceClinical Research Coord III
Duties noted above plus :
Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocolsEnsure 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 / auditorsDirect the activities of research support staff. Assist with the training of staffDevelop 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) processesSr Clinical Research Coord
Duties noted above plus :
Responsible for internal review / monitoring of clinical data for quality assurance purposes. Reports findingsResponsible 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 metContribute 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 staffPrepare ongoing summary reports from various data sources, and collaborate with investigators on data presentation, interpretation, and the writing of manuscripts for publication and grant proposalsIdentify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding complianceAccountable for quality assurance reviews of study dataAssist 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) processesQualifications
REQUIRED QUALIFICATIONS :
Clinical Research Coord I :
Bachelor's degree in a scientific or health related field, or equivalent experience0-1 year of related experienceAbility to travel off site locationsClinical Research Coord II :
Requirements noted for CRC I plus :1-3 years of related experienceClinical Research Coord III :
Requirements noted for CRC I plus :3-5 years of related experienceSr Clinical Research Coord :
Requirements noted for CRC I plus :5-7 years of related experienceDemonstrated knowledge of quality management principles in a scientific or hospital setting