Clinical Research Coordinator, Open Rank

About the Role

This is an open-rank Clinical Research Coordinator position with four distinct levels, hiring candidates commensurate with their experience. The role is responsible for independently performing delegated tasks and procedures involving human subject research, including coordination of regulatory activities and data management for treatment, ancillary services, and prevention practice research protocols.

Key Responsibilities

• Clinical Research Coord I:

• Obtain consent from research participants in accordance with IRB-approved protocols and 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 and report issues with protocol compliance to the principal investigator and manager.

• 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 grants 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.

• Monitor 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, therapeutic checklists).

• Maintain strict adherence to all study protocols and regulatory requirements, adhering to federal, local, and institutional guidelines.

• Comply with all safety and infection control standards.

• Adhere to established policies, health and safety regulations, procedures, and department objectives.

• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices.

• Practice discretion and adhere to school and hospital confidentiality at all times.

• Perform other duties as required.

• Clinical Research Coord II (in addition to CRC I duties):

• Conduct preliminary quality assurance reviews of study data.

• Contribute to data presentations and 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.

• Document and collect data/samples for research-related procedures performed during participant study visits and ensure clinician/PI documentation accuracy.

• Monitor strict adherence to all study protocols and regulatory requirements and identify and resolve issues with protocol compliance.

• Clinical Research Coord III (in addition to CRC II duties):

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

• Ensure accuracy and completion of all regulatory documentation and provide data/support to Investigators, sponsors, and/or external monitors/auditors.

• Direct the activities of research support staff and assist with their training.

• Develop preliminary designs for study-related documentation of data and collection tools.

• Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations, and IRB processes.

• Sr Clinical Research Coord (in addition to CRC III duties):

• Responsible for internal review/monitoring of clinical data for quality assurance purposes, reporting findings.

• Responsible for the smooth operation of all assigned studies, interacting with investigators, staff, clinicians, and sponsors 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.

• May supervise the activities of research support staff, assisting with selection, training, and supervision.

• Prepare ongoing summary reports from various data sources and collaborate with investigators on data presentation, interpretation, and manuscript writing for publication and grant proposals.

• Identify and resolve issues with protocol compliance, keeping the principal investigator and manager informed.

• Accountable for quality assurance reviews of study data.

• Assist with financial/operational aspects of grants and contracts and is responsible for clinical research billing review within the required timeframe.

• Contribute independently to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations, and IRB processes.

WASLI Initiative Specifics

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. Responsibilities include ensuring successful implementation of the curriculum, leadership activities, participant engagement, and program evaluation. The role will manage regional recruitment, onboarding, communications, logistics, and ongoing support for participants, coaches, and mentors. Additionally, it will oversee regional project activities, including travel coordination, leadership project monitoring, and reporting requirements. Project staff will support the WASLI mentor through coordination, scheduling, resource sharing, and communication to align with program goals.

Requirements & Tech Stack

• HIPAA
• Institutional Review Board (IRB)
• Good Clinical Practice (GCP)
• WASLI
• ATTC National Coordinating Office (NCO)
• New England ATTC
• Data management systems
• Scientific or hospital settings

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 to 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.