Remote Study Enrollment Lead

Summary

Join us today as a Study Enrollment Lead to optimize trial enrolment by communicating with site staff, coaching CRAs, and ensuring active site recruitment plans are in place. This role requires successful collaboration with colleagues, particularly Clinical Operations and Project Leadership.

Requirements

• Minimum Required: Advanced degree in life sciences discipline or equivalent experience
• Other required: 4 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Extensive experience in clinical development focused on strategy and execution of all phases of clinical trials

Responsibilities

• Support the development and execution of site enrolment strategies and tactics appropriate to the awarded study needs and in alignment with sponsor requirements
• Successfully deliver training to all current and onboarding Precision for Medicine CRAs and CTMs on effective study recruitment and retention communication with site staff
• Coach CRAs on an ongoing basis to ensure successful implementation of skills learned during recruitment and retention training
• Train CRAs on all elements of the patient engagement strategy in partnership with the Senior Patient Engagement Lead prior to each study’s first SIV
• Lead the organization to ensure that every site on every new and ongoing study has a site recruitment plan in place (excluding first in human trials) and that it is revisited with the site either quarterly or sooner if recruitment begins to lag
• Work as an SME for project teams to troubleshoot recruitment and retention challenges on ongoing trials
• Recommend patient engagement strategies for rescue studies, from either or both of the following: Site-based communication support for CRAs Broader strategies to facilitate site referrals, outreach, patient education etc., devised in partnership with the Senior Patient Engagement Lead
• Communicate with sponsors and project teams to implement and monitor impact of study enrolment tactical plans. Make additional operational and tactical recommendations as needed based on study performance
• Represent Precision for Medicine at site/sponsor-facing meetings e.g., KOMs, IMs, to present strategy/rationale, train site staff, and conduct recruitment support workshops as required
• Contribute to bid defense meeting prep and attend bid defense meetings, particularly where study enrolment support is required
• Maintain knowledge of current site and patient engagement trends, vendors, and technologies to increase productivity and recommend additional support as needed
• Develop and implement risk management plans
• Provide technical expertise in support of project specific and interdepartmental training efforts
• Contribute to thought leadership activities as needed
• Support continued process improvement to ensure quality in the department

Preferred Qualifications

Graduate, postgraduate degree

Benefits

• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation, among other benefits