Description
The Clinical Research Liaison (CRL) will serve as a key liaison between Clinical Operations group and the sites and site personnel (e.g. study coordinators, investigators) for all clinical trials to ensure optimal conduct and implementation of trials with regards to enrollment and compliance with GCP and regulatory requirements. The CRL will develop and maintain professional relationships with study-center healthcare providers, including clinical trial investigators, study nurses/coordinators, data coordinators, and other study professionals to support patient recruitment activities. In addition, the CRL will be a resource for study monitoring or clinical study management to Clinical Operations.Responsibilities will include:
? Serve as key liaison between Clinical Operations group and the sites and site personnel (e.g. study coordinators, investigators) for all clinical trials.
? Engage and establish relationships with clinical site personnel conducting clinical trials through on-site meetings and interactions to continuously support patient recruitment activities.
? Serve as a clinical trial resource for sites and site personnel.
? Work closely with sites and site personnel to develop study and/or site patient recruitment and retention tactics
and strategies appropriate to the individual study needs.
? Generate and monitor enrollment modeling scenarios and continuously evaluate the recruitment projections for improvements or triggers to support the implementation of action and/or contingency planning.
? Coordinate with clinical study staff to identify and interact efficiently to maximize use of site resources for effective study recruitment.
? Provide effective presentations to sites, site personnel, groups, and participating in 1:1 discussions, tailoring discussions to meet specific recruitment needs.
? Serve as a study-specific educational resource to the clinical trial study site personnel.
? Communicate information obtained from appropriate field interactions to internal staff.
? Maintain a high standard of integrity and professionalism in the study-site community.
? Keep abreast of changes in treatment trends that could impact clinical trials.
? As requested, conduct study Site initiation visits, routine monitoring visits, or study close-out visits and provide operational support to Clinical Operations.
? Participate in training and staff meetings with Clinical Operations.
? Capable of anticipating obstacles and proactively develop solutions to achieve project goals.
? Maintain operational, GCP and regulatory compliance at all times
Position Qualifications:
? BA/BS degree in a life science field or other relevant discipline if paired with commensurate clinical trial experience.
? At least 2 years previous experience as clinical study coordinator, monitoring/clinical research associate or clinical project management experience of industry sponsored clinical trials; knowledge of drug development process and FDA and ICH regulations and guidelines.
? Demonstrated computer skills (MS Office, MS Project, PowerPoint).
? Strong business communication skills (written; verbal; presentation). ? Strong initiative and ability to identify issues and create solutions.
? Prior experience guiding and mentoring clinical study staff.
? Ability to travel up to70% to domestic locations.
? Prior patient recruitment or strategic patient recruitment planning experience is desirable.