Training Program Title

Clinical Research Orientation

Contributor

Mayo Clinic

CTSA Hub Administered

yes

Contact Information

simmons.william1@mayo.edu

Training Program Description

Using a standardized model for onboarding, new clinical research study staff will develop and increase the knowledge and skills needed to coordinate clinical research protocols while working cooperatively with personnel at all levels. This 10-day orientation consists of approximately 20 hours of online modules, 20 hours of facilitated topics and activities and 40 hours on-the-job training. Participants will be part of a cohort that meets daily (approximately 2 hrs/day) for facilitated topics and activities. The remainder of the time will be either participating in online module or in mentored on-the-job training. Clinical Research Orientation is open to all Research units. While priority will be given to new staff who are orienting to ACRC, CRC, or RN CRC roles and those who have been in the role for 2 months or less, others are welcome to register. Orientation is held on-site in Rochester. Offsite participation via A/V conference is available for Florida, Arizona, and Mayo Clinic Health Systems.

Competency Keywords

Clinical trial, Communication, Teamwork, Translational teamwork, Workforce development, Research study staff

Other Keywords

Workforce Development

Digital Commons Disciplines

Medical Education

Public

no

Cost to Access

no

Competency Domains

Scientific Concepts and Research Design; Ethical and Participant Safety Considerations; Medicines Development and Regulation; Clinical Trials Operations; Study and Site Management; Data Management and Informatics; Leadership and Professionalism; Communication and Teamwork

Learning Objectives

Orientation Objectives

  1. Provide overview of basics of clinical research
  2. Introduce resources for support and coordination of protocols
  3. Allow employees to experience their work unit right away and build connections and context

At the end of the orientation, participants will be able to:

  1. Recognize the basic principles of human subjects protection (Belmont report - respect for persons, benefice, justice | Code of Federal Regulations - 45 CFR)
  2. Recognize the importance of their role in Good Clinical Practice (best practices for collecting and managing data, International Conference Harmonization Guidelines, FDA Regulations - 21 CFR)
  3. Identify the key activities involved in coordinating a clinical research protocol (protocol management, subject coordination, data management, protocol administration/business processes, protocol development & maintenance)
  4. Locate online resources to support the coordination of a clinical study
  5. Begin to build a list of professional contacts to support the coordination of a clinical study

Delivery Method

Combination of online and in-person

Target Learners

Clinical Research Professionals (other than PI)

Learning Level

Fundamental

Onboarding

yes

Frequency

Quarterly

Time Needed

80 contact hours - 20/20/40 model in two weeks 20 hours of online modules, 20 hours of in-person Subject Matter Expert guided instruction & 40 hours of in the work unit job shadowing with a mentor

Associated Assessment

yes

Assessment Methods

Overall satisfaction

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