The Strategist, Patient Recruitment & Site Engagement works with the Director, Patient recruitment and the Specialist, Digital Marketing Specialist in supporting patient recruitment strategies and site engagement.

This role will be perfect for you if:

• Have experience with patient recruitment programs and strategy
• Have experience with NA and EU clinical trials
• You understand GDPR and EU regulations for clinical trials and you are able to support US/CAN studies
• Have experience as a study coordinator at a large study site managing multiple trials

More specifically, the Strategist, Patient Recruitment and Site Engagement must:

• Develop the project level recruitment strategy plan in collaboration with the Patient Recruitment Team.
• Inform and train project team on recruitment strategy in collaboration with the Project Manager and/or CTM.
• Participate in BD handover, Kick off Meeting as well as Investigator meeting.
• Attend internal and external core and cross-functional team meetings.
• Provide patient recruitment training slides for SIV and/or CRA training.
• Develop site recruitment materials based on approved recruitment strategy.
• Work in collaboration with regulatory team to obtain approval of materials.
• Manage translations through the selected vendor(s) or local qualified translators and review of recruitment materials, where applicable.
• Manage distribution of materials to sites, where applicable.
• Monitor the progression of subject enrolment to ensure the target can be achieved and propose improvements in recruitment and retention strategies, as necessary, in collaboration with the Project Manager/CTM and/or clinical team. Identify risks, and plan risk management strategies.
• Work collaboratively with the clinical team for site communication and support.
• Collaborate with Project Team members to create recruitment models based on information obtained during feasibility, site initiation, actual recruitment performance.
• Assists the Project Manager on client’s request for recruitment and advertisement.
• Interacts directly with clients to establish and gain client input on recruitment strategies and budgets.
• When applicable, offers guidance to sites on ways to achieve their recruitment target using their advertisement budget.
• When applicable, review site advertisement for alignment to protocol and obtains Sponsor approval.
• When applicable, ensure the assigned study has been set-up and maintained appropriately in Clinago as per internal processes. 
• When applicable, ensure sites are onboarded and trained on the Clinago platform for central campaign initiative.
• When applicable, work with sites and monitor referrals from central campaign to ensure follow up is occurring at the site level.
• Ensure that all project relevant documentation is sent for filing in eTMF and archiving.
• Coordinate global advertisement IRB submission and approval process.

IDEAL PROFILE

Education

• BA/BS required, preferably in Communications or related field with 3 years relevant experience 

Experience 

• Minimum of 2 years of relevant work experience in the biotechnology, pharmaceutical or CRO or health/medical communication industry

Knowledge and skills

• Knowledge of good clinical practice, ICH standards and applicable regulations
• Good knowledge of European regulations/guidelines
• English spoken and written, Spanish or French an asset
• Experience in a research site environment an asset
• Experience managing Patient advocacy group an asset
• Experience in Patient recruitment strategies
• Problem solving skills, good adaptability, versatile, and great attention to details
• Strong organizational, communication, problem-solving and multi-tasking skills
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.