Clinical Research Coordinator

4 days ago

Amherst, United States UMass Amherst Full time

About UMass Amherst

UMass Amherst, the Commonwealth's flagship campus, is a nationally ranked public research university offering a full range of undergraduate, graduate and professional degrees. The University sits on nearly 1,450-acres in the scenic Pioneer Valley of Western Massachusetts, and offers a rich cultural environment in a bucolic setting close to major urban centers. In addition, the University is part of the Five Colleges (including Amherst College, Hampshire College, Mount Holyoke College, and Smith College), which adds to the intellectual energy of the region.

Job Summary

The Clinical Research Coordinator and Project Manager in the Center for Human Health and Performance (CH2P) in the Institute for Applied Life Sciences (IALS), will be responsible for a large array of procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for research protocols.

Essential Functions

  • Serves as the CH2P project lead for studies of moderate to high complexity from protocol implementation through study conduct and closeout in compliance with Good Clinical Practices, all human subject protection practices, University procedures, and all Global, National and Local Regulations.
  • Assists with development of materials for IRB submissions and amendments. Prepares and reviews study-related or essential study start-up documents as they relate to research studies (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Manual, etc.).
  • Develops REDCap and Study Standard Operating Manuals.
  • Conducts study visits for human subjects studies, as related to skills including administering questionnaires, conducting physical performance tests, blood draws, and/or other study-related tasks.
  • Ensures recruitment and screening of study participants to meet study objectives. Assists with recruiting, screening, enrolling, and terminating participants. Screens participants according to study criteria, randomizes, enrolls, and administers consent in accordance with Good Clinical Practice standards. Identifies and resolves issues with protocol compliance. Obtains consent of research participants in accordance with the IRB-approved protocols and all applicable regulations including HIPAA, as appropriate.
  • Implements and oversees study staff delegations/responsibilities. Serves as a Project Manager ensuring that the study team meets or exceeds the timelines and deliverables assigned to the study team. Establishes an effective working relationship with the project team, demonstrating respectful relationships and clear, effective and considerate communication. Responsible for protocol specific training of the study team.
  • Communicates with study sponsors in both academia and industry.
  • Maintains and manages relationships with Principal Investigators and community partners. Reviews and identifies project study trends and proactively responds to client and respective team members. Identifies and establishes relationships with new Principal Investigators and community partners based on current needs.
  • Facilitates day-to-day activities with IALS summer interns, student workers, and research assistants.
  • Contributes to continuous improvement activities/initiatives; in conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs, such as SOPs, working practices, and related quality assurance forms within the Core Facility.

Other Functions

  • Performs other duties as assigned.

Minimum Qualifications (Knowledge, Skills, Abilities, Education, Experience, Certifications, Licensure)

  • Master's degree in Exercise Physiology and 600 hours of clinical experience; or Bachelor's degree and 1200 hours of clinical experience.
  • Eligible to perform DXA scans within the Commonwealth of Massachusetts as defined by 105 CMR: 120.410 at time of employment.
  • Eligible (from an academic & clinical experience standpoint) to take the ACSM Clinical Exercise Physiologist certification.
  • Experience implementing Good Clinical Practice guidelines.
  • Certified Phlebotomist.
  • Experience with human subject research screening and consenting.
  • Experience in Cardiometabolic testing.
  • DXA - ISCD certified or in training program.
  • Experience with VO2 testing.
  • Ability to maintain Cardiometabolic equipment.
  • Ability to conduct training on Cardiometabolic equipment with Core users.

Preferred Qualifications (Knowledge, Skills, Abilities, Education, Experience, Certifications, Licensure)

  • Experience conducting and coordinating research with older adults and/or clinical populations.
  • Experience designing projects and utilizing REDCap for study execution.

Physical Demands/Working Conditions

  • Typical office environment.
  • Typical lab environment.

Additional Details

  • This is a 2-year, term-limited position.
  • Continuation of the position is contingent upon funding.

Work Schedule

  • Monday - Friday, 8:30am - 4:30pm, 37.5 hours per week.
  • May include occasional evening or weekend hours depending on ongoing experiments, but most often will be Monday - Friday.

Salary Information

Level 26

Exempt Hiring Ranges

Special Instructions for Applicants

Along with the application, please submit a resume and cover letter. References will be checked at the finalist stage. Please be prepared to provide contact information for three (3) professional references. Applications will be reviewed on a continuous basis until the position is filled. Early submissions are encouraged.

UMass Amherst is committed to a policy of equal opportunity without regard to race, color, religion, caste, creed, sex, age, marital status, national origin, disability, political belief or affiliation, pregnancy and pregnancy-related condition(s), veteran status, sexual orientation, gender identity and expression, genetic information, natural and protective hairstyle and any other class of individuals protected from discrimination in employment, admission to and participation in academic programs, activities, and services, and the selection of vendors who provide services or products to the University. To fulfill that policy, UMass Amherst is further committed to a program of affirmative action to eliminate or mitigate artificial barriers and to increase opportunities for the recruitment and advancement of qualified minorities, women, persons with disabilities, and covered veterans. It is the policy of UMass Amherst to comply with the applicable federal and state statutes, rules, and regulations concerning equal opportunity and affirmative action.

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