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Clinical Research Associate I

2 months ago

Worcester Massachusetts, United States University of Massachusetts Medical School Full time

Overview:

POSITION SUMMARY:


Under the supervision of the Principal Investigator (PI) or designated representative, the Clinical Research Associate I is tasked with autonomously executing assigned responsibilities and procedures related to human subject research.

This role encompasses the coordination of regulatory functions and the management of data collection for research protocols focused on treatment, ancillary services, and preventive measures.


Responsibilities:

ESSENTIAL FUNCTIONS:
Secure informed consent from research participants in compliance with IRB approved protocols and all relevant regulations, including HIPAA

Identify, schedule, and/or conduct participant study visits, interviews, and assessments

Facilitate participant remuneration/compensation in accordance with the protocol

Maintain comprehensive regulatory documentation, including local or central IRB and study data. Provide data and support to study Investigators, sponsors, and/or external monitors/auditors

Recognize and report issues related to protocol compliance. Keep the principal investigator and manager informed of any compliance-related concerns

Document and gather data and/or samples for research-related procedures conducted during participant study visits.

Ensure that clinicians and/or the PI accurately record their study activities as per protocol

Monitor and maintain study enrollment and the achievement of milestones

Assist with the financial and operational aspects of grants and contracts. May oversee clinical research billing reviews within the designated timeframe.

Track and maintain study-related information in the data management system within the required timeframe

Responsible for overseeing the inventory of research-related supplies

Engage in grant preparation, manuscript writing, data presentations, and Institutional Review Board (IRB) processes

Provide detailed written summaries from literature reviews and related sources to serve as a resource for the study team and clinicians/PIs

Present updates on study status related to assigned research projects

Contribute to the design, development, and documentation of study-related data and collection tools, such as questionnaires, treatment data, and/or therapeutic checklists

Maintain strict adherence to all study protocols, including all regulatory requirements in accordance with appropriate federal, local, and institutional guidelines.

Comply with all safety and infection control standards relevant to this position

Adhere to established policies, health and safety regulations, and departmental objectives

Follow Good Clinical Practice (GCP) guidelines and all human subject protection practices

Exercise discretion and uphold confidentiality at all times

Perform additional duties as required.

Qualifications:

REQUIRED QUALIFICATIONS:
Bachelor's degree in a scientific or health-related discipline, or equivalent experience

0-1 year of relevant experience

Willingness to travel to off-site locations

Additional Information:
Exceptional attention to detail

Ability to manage multiple tasks and projects simultaneously

Flexibility to adjust priorities in work assignments as necessary

Capacity to work independently while seeking guidance when needed.