Kelly Science and Clinical FSP is currently seeking a Sr. CRA for a long-term engagement in Quebec with one of our Global Medical Device clients. This is a remote based opportunity. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. Therapeutic Experience Candidates must have complex cardiac experience within the past 5 years, preferably in electrophysiology and / or devices.
Examples provided for reference, not an all-inclusive list: 
· Best- device examples: Ablation catheters, pacemakers, ICDs, LAACs, stents, valves
· Good- pharm examples: Rhythm disorders, myocardial infarction
· Not sufficient: Hypertension, hyperlipidemia General Experience · A plus:
o CRA training or bridge program through a reputable organization / employer
o Clinical background
· In-depth knowledge of applicable regulations and ICH/GCP guidelines.
· Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
· Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
· Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
· Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
· Ability to work independently and manage multiple priorities in a dynamic environment.
· A well-executed plan for communication with the study teams and sites.
· Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports. Site Manager-specific responsibilities · Study Start-up:  
· Contracts 
· SM meets regularly (typically weekly) with the Contract Specialist for status update on contracting/budget negotiations for each sites 
· SM reaches out to site as necessary (e.g. if site has been unresponsive with the Contract Specialist) 
· SM provides contract/budget updates to study leadership on a regular basis 
o EC Submission: SM provides regulatory documents to sites, including ICF to site for submission to EC 
o ICF Review and approval (throughout trial): SM reviews initial draft site ICF (provided by site to SM) to confirm all study related requirements are included in the ICF; completes ICF checklist to confirm all required elements are included in ICF (ICF Checklist is complete prior to submission to EC and following approval from EC)
o Study Activation Checklist: SM complete SAC and sends document for signature by study lead 
o Enrollment Activation Letter: SM sends site Enrollment Activation Letter, confirming site authorization for consenting participants into the study