Clinical Affairs Associate
- Expired: over a month ago. Applications are no longer accepted.
Clinical Affairs Associate
Here at SRG, our client is looking for a Clinical Affairs Associate to join the Scientific and Medical Affairs team!
About the Opportunity
- This role is remote, with some nation wide travel required.
- Flexible hours, full time, and perm- this is a great opportunity to find a long term home!
- Our client is a commercial stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced.
- The primary objective of the Clinical Affairs Associate is to conceptualize, plan, design, execute and monitor clinical field trials required as part of the licensing and registration of the medical device instrument and consumable products in development.
What the Clinical Affairs Associate will be doing:
- The planning and management of assigned clinical field trials related to product including management of potential Contracted Research Organizations field trials in foreign countries.
- Perform site co-ordination, initiations, monitoring visits and close out visits as required.
- Develop clinical case report forms, final reports, clinical investigator brochures and clinical trial protocols.
- Responsible for the completion, compliance and assessment of safety / efficacy reports as required by the FDA and international regulatory bodies, clinical development plans, and research strategies.
- Collaborates with Finance team to negotiate and execute investigator agreements and administer contracts.
- Collaborates with the Sales team, providing visibility of trial status.
- Prepares monthly reports and project updates for submission to management.
What the Ideal Candidate Brings:
- Relevant Degree or professional qualification is essential e.g., Scientific or Medical Technology. Clinical Affairs Professional Society Certification is desirable.
- Significant experience (approx. 2-5 yrs) in a clinical affairs role with specialist knowledge of clinical affairs applied to in vitro diagnostic medical devices.
- Must have a working knowledge of ISO 13485 and IVDD requirement. Experience in filing BLA, 510(k) and BLA/ PMA submissions, CE marks is desirable.
- Understanding and experience of working in a regulated manufacturing environment (GMP, GDP, GLP).
- High degree of technical competence with strong team working and project management skills.
- Confident and customer focused with strong verbal and written communication skills.
- Competitive salary on offer with range of company benefits including healthcare, 401k plan and various insurances.
- Up to 25-30% travel across US, with occasional European Travel.
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SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.