Clinical Research Associate (Remote – Home Office)

Our Biotech client is expanding!  We are seeking an experienced Clinical Research Associate.  (Remote – Home Office).  Travel will be required, nationally and internationally.

The Clinical Research Associate will be responsible for all the monitoring activities of clinical studies performed by our client. The CRA will coordinate the activities from sites identification to close-out visits, will monitor clinical studies and will oversee the CROs monitors. This position will also require maintaining and preparing study documentation along with participating in the clinical development strategies.

Responsibilities

  • Monitor and oversee clinical activities from the start-up to the completion of the trials
  • Develop and ensure adherence to clinical trial timelines
  • Participate in the design, planning and implementation of clinical trials
  • Prepare, review and approve trial-related documents
  • Ensure proper communication of study progress to stakeholders
  • Identify, lead and manage CRO monitor
  • Responsible for the quality and compliance with protocols and study procedures and ensure audit readiness
  • Collaborate in the development of clinical SOP and guidelines
  • Communicate and support clinical investigators
  • Coordinate and manage the Investigational Product and clinical samples operations.
  • Participate in the analysis of clinical trial results

Qualifications

Mandatory Education- Degrees, Licenses, Certifications:

Bachelor degree in biological sciences (or equivalent) OR Registered Nurse

Additional Valuable Education-Degrees, Licenses, Certifications:

Clinical Research Certificate

Skills and Abilities

  • Strong negotiation, communication and organization skills
  • Detail oriented and ability to prioritize
  • Show adaptability and empowerment
  • Capacity to work under pressure and tight timelines
  • Experience with CRO and vendors selection (RFP, Bid Defense)
  • Strong scientific knowledge
  • Strong understanding and knowledge of GCP and ICH guidelines

For additional information, please contact Cynthia McCutcheon:  cynthia@summitsearchgroup.com

Summit Search Group would like to thank everyone who applies but only those who match the criteria will be contacted for follow up discussions.

Job ID

CM2072

City

Montreal, QC

Remuneration

Depends on Experience

Recruiter

Categories:    Project Management    Technician and Technologist    Other   

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If your qualifications are a match for this position please apply online for immediate consideration. Thank you for your application.

Position Applying For:

Clinical Research Associate (Remote – Home Office)

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