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Full-time

Clinical Research Coordinator - Open Rank

Competitive

Worcester, MAScience & PharmaceuticalPosted 17d ago

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Role overview

Job type

Full-time

Salary

Competitive

Posted

17 days ago

Job description

UMass Chan Medical School is seeking a Clinical Research Coordinator to independently perform delegated tasks and procedures involving human subject research under the direction of a Principal Investigator or designee. The role coordinates regulatory activities, participant visits, data and sample collection, study documentation, compliance, and research operations across multiple open-rank levels, while also supporting the WASLI initiative through recruitment, participant engagement, logistics, evaluation, and leadership development activities.

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, 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

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

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

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

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 as needed, ensuring successful implementation of the curriculum, leadership activities, participant engagement, and program evaluation. He will manage regional recruitment, onboarding, communications, logistics, and ongoing support for regional participants, coaches, and mentors, while also overseeing regional project activities, including travel coordination, leadership project monitoring, and reporting requirements. In addition, project staff will support the WASLI mentor through regular coordination, scheduling, resource sharing, and communication to ensure alignment with program goals and successful delivery of mentorship, coaching, and leadership development activities for participants

Benefits

Work Location: Hybrid

Company

Public academic health sciences center training doctors and scientists

Worcester, Massachusetts, USA

https://www.umassmed.edu/

Founded in 1962

5001-10000 employees

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

1-3 years of related experience

3-5 years of related experience

5-7 years of related experience

Demonstrated knowledge of quality management principles in a scientific or hospital setting

Required skills

Represents the skills you have, click on the tags

Preferred skills

Quality Management Principles

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