Apply on Employer Site

UMass Chan Medical School · 4 hours ago

Clinical Research Coordinator I

Worcester, MA

Full-time

Hybrid

New Grad, Entry Level

0+ years exp

UMass Chan Medical School is seeking a Clinical Research Coordinator I to perform delegated tasks and procedures involving human subject research. The role involves coordinating regulatory activities, managing data collection for research protocols, and ensuring compliance with applicable regulations.

Higher Education

Responsibilities

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, interviews, and tests

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

Qualification

Clinical Research CoordinationRegulatory ComplianceData ManagementClinical Practice (GCP)Human Subject ProtectionCommunication SkillsTeam CollaborationProblem Solving