The Strategist, Patient Recruitment & Site Engagement works with the Associate 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.

Requirements:

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.
  Our company:

• 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 trial