Page 61 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R004 SOP Title: Coordinating an Introduction with the PI
1. PURPOSE
The purpose of the current standard operating procedure (SOP) is to define the team leader’s initiative to bridge communication with a new clinical research coordinator (CRC) or associate (CRA) in Research Administration (RA) with the principal investigator(s) (PI) on their study assignments.
2. INTRODUCTION
RA hires new CRC’s or CRA’s as they see fit, for a specific set of study assignments. This allows leadership to effectively plan the new team member’s integration into their role in the department. As part of a new team member’s orientation to the RA, the team leader helps orient them to their study assignments and respective service line(s) and PI(s).
In effort to effectively assimilate the new team member, it requires that the team leader inform the assigned PI(s) of the new team member’s expected start date prior to their arrival. Upon the team member’s arrival, the team leader will facilitate an introductory meeting in order that the new CRC or CRA and their PI(s): 1) get acquainted, 2) review the study and the study status, 3) and define the expectations of the study and its conduct.
3. SCOPE
The procedures defined in the current SOP apply to all CRCs and CRAs and their direct supervisor/team lead at RA. Routine and effective communication among the study team members is an expectation within the scope of Good Clinical Practice (GCP).
4. RESPONSIBILITIES
4.1 Preparation of the Orientation
The hiring process is informed by leadership’s assessment of the study demands and workload analysis. A strategic hiring process informs both the new team member and RA staff of the study assignments and role. In preparation for the arrival of the new CRC or CRA, the clinical manager, the team leads, the educators, and administrator meet to plan the orientation and onboarding process. The agreements and contracts regarding the terms of the new team member’s employment are discussed in relation to their time dedicated to a particular study, service line, or PI.
Once the new team member’s orientation plan has been discussed, the team lead assigned to that CRC or CRA will then contact the PI(s) to schedule an introductory meeting. The meeting should range anywhere from 15 to 30 minutes and on the second week of the new team member’s employment depending on the PI’s availability.
4.2 Making the Introductions
Upon the new CRC’s or CRA’s arrival, the team lead will forward the outlook appointment to the new team member securing the time for the introductory meeting with their PI(s). Prior to the meeting, the team lead will orient the new team member to their new study assignments providing them with the study status, protocol, regulatory
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