University of Massachusetts Medical School

Public academic health center educating, researching.

Clinical Research Coordinator

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeWorcester, MA, USA$40k - $80k

About the Job

Requirements

Clinical Research Coordinator I requires a bachelor’s degree in a scientific or health-related field, or equivalent experience.
Clinical Research Coordinator I requires 0–1 year of related experience.
Clinical Research Coordinator I requires the ability to travel to off-site locations.
Clinical Research Coordinator II requires the Clinical Research Coordinator I qualifications plus 1–3 years of related experience.
Clinical Research Coordinator III requires the Clinical Research Coordinator I qualifications plus 3–5 years of related experience.
Senior Clinical Research Coordinator requires the Clinical Research Coordinator I qualifications plus 5–7 years of related experience and demonstrated knowledge of quality management principles in a scientific or hospital setting.

Responsibilities

Obtain research participant consent in accordance with Institutional Review Board-approved protocols, the Health Insurance Portability and Accountability Act, and applicable regulations.
Identify and schedule participants and conduct study visits, tests, interviews, and telephone follow-up calls.
Coordinate participant remuneration and compensation according to protocol.
Maintain regulatory documentation, including local or central Institutional Review Board records and study data, and provide data and support to investigators, sponsors, external monitors, and auditors.
Identify protocol-compliance issues and keep the principal investigator and manager informed; higher-level coordinators also resolve compliance issues.
Document and collect data and samples for research procedures during participant study visits, and ensure clinicians and principal investigators accurately document study activities according to protocol.
Track study enrollment, completion milestones, and study-related information in data-management systems within required timeframes.
Assist with financial and operational aspects of grants and contracts, including clinical research billing review as assigned.
Monitor inventory of research-related supplies.
Participate in grant preparation, manuscript writing, data presentations, and Institutional Review Board processes.
Prepare detailed written summaries from literature searches and related sources for the study team and clinicians or principal investigators.
Present study-status reports for assigned research projects.
Participate in designing, developing, and documenting study data and collection tools, including questionnaires, treatment data, and therapeutic checklists; higher-level coordinators contribute to or independently develop preliminary designs.
Comply with study protocols and regulatory requirements, including applicable federal, local, and institutional guidelines; Good Clinical Practice guidelines; human-subject protection practices; safety and infection-control standards; confidentiality requirements; and established policies, procedures, and department objectives.
Perform other duties as required.
Clinical Research Coordinator II conducts preliminary quality-assurance reviews of study data and contributes to data presentations and Institutional Review Board processes.
Clinical Research Coordinator III assists with recruiting, screening, selecting, maintaining, and terminating study subjects across multiple protocols; ensures regulatory documentation is accurate and complete; directs research support staff activities and assists with staff training; and contributes to grant preparation, protocol-feasibility assessment, manuscript writing, data presentations, and Institutional Review Board processes.
Senior Clinical Research Coordinator conducts internal clinical-data quality-assurance monitoring and reports findings; ensures smooth day-to-day operation of assigned studies and coordination with investigators, staff, clinicians, and sponsors to meet project timelines and goals; may supervise research support staff and assist with staff selection, training, and supervision; prepares summary reports and collaborates on data presentation, interpretation, manuscripts, and grant proposals; and is accountable for study-data quality-assurance reviews and clinical research billing review.
For the lupus research portfolio, identify, screen, and recruit eligible patients from rheumatology clinics and obtain and document informed consent.
Coordinate study visits according to protocol schedules, including scheduling, conducting visits, and follow-up.
Collect, process, and ship biospecimens, including blood, urine, and other samples, according to protocols and laboratory manuals; maintain sample logs and chain of custody.
Administer questionnaires, collect patient-reported outcomes, and abstract clinical data from medical records.
Enter data into electronic data-capture systems and registry platforms and resolve queries promptly.
Maintain regulatory files and support Institutional Review Board submissions, amendments, continuing reviews, and adverse-event reporting.
Prepare for and participate in sponsor monitoring visits and audits.
Track enrollment and visit metrics and communicate study status to investigators and sponsors.
Collaborate with investigators, research laboratory staff, and the study team across concurrent protocols.

Desired Qualifications

Prior clinical research experience.
Familiarity with Good Clinical Practice and human-subject protections.
Phlebotomy or specimen-handling experience.

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 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:

Bachelor’s 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

Additional Information

Clinical Research Coordinator, Division of Rheumatology, Lupus Research Program

The Clinical Research Coordinator supports a portfolio of lupus studies within the Division of Rheumatology, including the Lupus Nexus registry and biorepository, the CurLi translational study, and industry-sponsored and investigator-initiated clinical trials in systemic lupus erythematosus.

Duties include:

Identify, screen, and recruit eligible patients from rheumatology clinics; obtain and document informed consent
Coordinate study visits in accordance with each protocol’s schedule of events, including scheduling, visit conduct, and follow-up
Collect, process, and ship biospecimens (blood, urine, and other samples) per protocol and laboratory manuals; maintain sample logs and chain of custody
Administer questionnaires and collect patient-reported outcomes; abstract clinical data from the medical record
Enter data into electronic data capture systems and registry platforms with timely query resolution
Maintain regulatory files and support IRB submissions, amendments, continuing reviews, and adverse event reporting
Prepare for and participate in sponsor monitoring visits and audits
Track enrollment and visit metrics; communicate study status to investigators and sponsors
Collaborate with investigators, research laboratory staff, and the study team across concurrent protocols

Preferred: prior clinical research experience, familiarity with GCP and human subjects protections, phlebotomy or specimen handling experience.

Compensation: 40000 to 80000 (USD)

About the Company

University of Massachusetts Medical School

Public academic health center educating, researching.

Public academic health sciences center that educates future doctors, scientists and nurses; conducts biomedical and clinical research; and runs clinical trials while providing health‑care services through its graduate schools and the ForHealth Consulting and MassBiologics divisions. ForHealth Consulting offers care management and consulting to improve care delivery and health policy for government agencies, nonprofits and health care organizations. MassBiologics develops and produces vaccines, plasma derivatives and monoclonal antibodies at an FDA‑licensed nonprofit facility. The school’s goal is to advance medicine by training leaders, conducting collaborative research and translating discoveries into practical health solutions that raise health outcomes for families and communities.

Company size: 5,001-10,000
Company stage: Grant
Total funding: $182.6M
Headquarters: Worcester, MA
Founded: 1962

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