Clinical Trial Liaison

JOB DESCRIPTION:

The primary responsibility of the Clinical Trial Liaison (CTL) is to manage assigned clinical sites during the life cycle of clinical research: study start-up activities, study recruitment, device implantation, and follow-up study phases. In addition, the CTL will support site initiation visits, clinical education, data collection oversight, implementation of subject recruitment strategies, and communicating with appropriate site staff and investigators for the successful completion of clinical studies.

RESPONSIBILITIES:

• Work with both the clinical and administrative departments, and the hospitals to create a collaborative and strong research relationship.
• Educate and train site research staff on the clinical protocol and scientific rationale for products.
• Must be able to communicate current and relevant heart failure, device data, and clinical trends as they relate to the appropriate use of products and the treatment of our targeted study population.
• Attend clinical cases and/or study follow-up visits as needed to ensure proper data collection and adherence to protocol.
• Perform, oversee, and work closely with in-house or contracted staff to completely and accurately comply with GCP guidelines in the collection of study data.
• Achieve regional enrollment goals on a monthly, quarterly, and annual basis
• Develop a strong working relationship with all members of the clinical affairs team.
• Collaboration with other functional domains of the organization to achieve common goals.
• Facilitate opening new regional clinical trial sites in a timely manner
• Ensure that study-related issues at assigned sites are well documented and resolved in a timely manner.
• Ensure that all regulatory requirements of clinical trial reporting at assigned sites are met accurately and expeditiously
• Capture clinical experiences at sites to improve understanding of product behavior, improve product performance and product acceptance by customers.
• Coordinate and support educational activities as requested.
• Accelerate enrollment through subject referral and awareness initiatives

QUALIFICATIONS:

Education:

• Bachelor’s or graduate degree in Life Sciences, Nursing, Biomedical Engineering, or equivalent education/experience

Required:

• 5+ years of experience in Life, Health Sciences, Nursing, or Biomedical Engineering field
• 5+ years of experience in Clinical research
• Strong working knowledge of the medical device industry
• Proven ability to develop new clinical relationships and foster existing clinical relationships
• Familiarity with Good Clinical Practice, ISO, and 21 CRF regulations pertaining to clinical research
• Experience training investigators and research teams on clinical protocols
• Excellent oral and written communication skills