Page 457 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Com-100
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 of a newly assigned clinical research coordinator (CRC) or associate (CRA) in Research Administration (RA) with the principal investigator(s) (PI) on their study assignments.
2. INTRODUCTION
A great deal of careful consideration goes into devising study coverage plans that advocate for continuity of patient’s care, effective progress of research goals, and in the support of the CRC/A’s work-life balance. The collaboration between the CRC/A and team leader to devise a study coverage plan involves successfully integrating the newly assigned team member into their role on the study or research portfolio. As part of this endeavour, the team leader and team member work together to ensure properly oriented into the ancillary department and team, and namely, their 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. Then 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) define the expectations of the study and its conduct, and 3) assess further orientation with the floor guidelines, policies, and processes (e.g., restricted access, scheduling, Omnicell management, and essential ancillary contacts, etc).
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 study assignment process is informed by leadership’s assessment of the study demands and workload analysis. In preparation for the arrival of the new CRC or CRA, the director and team leads develop an onboarding plan. For new hires, the director, research educator, and administrative coordinator develop a plan for the fully encompassed onboarding process for new hires (see SOP A003 Onboarding). 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.
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