Clinical Research Coordinator I at University of Massachusetts Medical School

Worcester, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Regulatory Compliance, Data Management, Participant Recruitment, Consent Process, Study Coordination, Documentation, Inventory Management, Financial Management, Good Clinical Practice, IRB Processes, Data Collection, Communication, Problem Solving, Confidentiality, Safety Standards

Industry

Business Consulting and Services

Description

POSITION SUMMARY: Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator I 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. ESSENTIAL FUNCTIONS: 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. REQUIRED QUALIFICATIONS: 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

Responsibilities

The Clinical Research Coordinator I is responsible for coordinating human subject research activities, including obtaining consent, scheduling participant visits, and maintaining regulatory documentation. They also track study enrollment and assist with financial aspects of grants and contracts.