Sr Clinical Research Associate - Canada
New Brunswick, New Jersey, United States of America
Contract
1 day ago
$180,000 USD
Key skills
Google CloudLeadershipCommunication
About this role
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.
Required Info Client Name Medtech J&J Client Project Name for Bullhorn Post Role (Yes or No) If no, what date can the role be posted? yes Kelly IOL/Client Lead Anthony Ryan Kelly Program Manager Kala Garrison Kelly Program Coordinator Laura McKinney Hiring Manager & Title Nina Swanson Position Title Sr CRA Top 3 Required Skills
Tentative sites: 3 in Quebec, 2 Vancouver, 3 Ontario Remote Details (Remote Or Hybrid) Hybrid (clinic travel required) Travel Expectations 10-12 days a month Is the HM willing to consider candidates open to relocation? (Are they open to paying a relocation fee for someone to be onsite) Detailed Interview/Hiring Process 1st M&G with Nina & Natalie
2nd with study team
MSA Status Approved Additional Detail (This will elevate the recruiting priority) Candidate needs to be fluent in French speaking, reading, and writing
SSU/SM experience is not required Internal notes for recruiting (i.e. position history, company culture, therapeutic area exp, system/software experience etc.): In your own words, how would you describe their normal routine: Where is the client in the search/hiring process? What would entice an A+ candidate to take this job? *Paste Full JD in same box under the template Location Canada Target Start July Candidate specifics 3 years of monitoring required Education A bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science. 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/Google Cloud Platform 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
First Cases:
o SM ensures study catheters are sent to site in preparation for all cases
Enters device Lot/Serial numbers, ship date, tracking information is entered into EDC
o SM notifies MA of first cases and coordinates availability for device training (typically first day of case)
o Attends first 3-4 cases; trains coordinator to data collection/device handling during procedure
Enrollment/Maintenance:
o Provides site level updates for Study CMR (at minimum, quarterly)
o Send Site Management Updates to sites monthly, or as necessary (depending on site performance)
o Report non-compliances to study lead and document in CTMS; follow-up to confirm that the non-compliance is close out
o Site payments:
Track, review, and approve invoices received from sites
Track study activities performed per quarter and report Latest Thinking (LTs) to Financial Coordinator quarterly, as requested (this included study activities completed within a given quarter, but not yet invoiced for by the site)
Required Info Client Name Medtech J&J Client Project Name for Bullhorn Post Role (Yes or No) If no, what date can the role be posted? yes Kelly IOL/Client Lead Anthony Ryan Kelly Program Manager Kala Garrison Kelly Program Coordinator Laura McKinney Hiring Manager & Title Nina Swanson Position Title Sr CRA Top 3 Required Skills
- Complex cardiac experience within past 5 years
- Electrophysiology medical device
- Fluent in French speaking, reading, and writing
Tentative sites: 3 in Quebec, 2 Vancouver, 3 Ontario Remote Details (Remote Or Hybrid) Hybrid (clinic travel required) Travel Expectations 10-12 days a month Is the HM willing to consider candidates open to relocation? (Are they open to paying a relocation fee for someone to be onsite) Detailed Interview/Hiring Process 1st M&G with Nina & Natalie
2nd with study team
MSA Status Approved Additional Detail (This will elevate the recruiting priority) Candidate needs to be fluent in French speaking, reading, and writing
SSU/SM experience is not required Internal notes for recruiting (i.e. position history, company culture, therapeutic area exp, system/software experience etc.): In your own words, how would you describe their normal routine: Where is the client in the search/hiring process? What would entice an A+ candidate to take this job? *Paste Full JD in same box under the template Location Canada Target Start July Candidate specifics 3 years of monitoring required Education A bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science. 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/Google Cloud Platform 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
First Cases:
o SM ensures study catheters are sent to site in preparation for all cases
Enters device Lot/Serial numbers, ship date, tracking information is entered into EDC
o SM notifies MA of first cases and coordinates availability for device training (typically first day of case)
o Attends first 3-4 cases; trains coordinator to data collection/device handling during procedure
Enrollment/Maintenance:
o Provides site level updates for Study CMR (at minimum, quarterly)
o Send Site Management Updates to sites monthly, or as necessary (depending on site performance)
o Report non-compliances to study lead and document in CTMS; follow-up to confirm that the non-compliance is close out
o Site payments:
Track, review, and approve invoices received from sites
Track study activities performed per quarter and report Latest Thinking (LTs) to Financial Coordinator quarterly, as requested (this included study activities completed within a given quarter, but not yet invoiced for by the site)