Burn Nurse - Clinical Research Liaison - West Coast
Burn Nurse - Clinical Research Liaison - West Coast
• Responsible for directing and managing the internal and external resources, clinical study sites and CROs to optimize recruitment to study.
• Responsible for providing Clinical front-line case support and Education to burns centers.
Clinical Recruitment Manager (50% time)
• Ensure the timely execution of the recruitment plan for U.S. sites participating in the study.
• Complete training on study protocol, electronic Clinical Report Forms, medical training (Including clinical data gathered to-date), all study guidelines (of all vendors), sites’ contracts and budget.
• Engage with principal investigators and site teams / staff via face to face visits, by phone, email
• Build strong relationships with site investigators and site teams/staff
• Support training to the clinical sites
• Provide timely updates to the Vericel’s Clinical Operations team and Clinical Program Manager (CPM)
• Support the operation of clinical studies and serve as a liaison between the medical centers. and the CRO
• Address, in in coordination with Vericel’s Clinical Operations Team, CPM and the CRO, any operational and performance issues
• As needed, assist the Company’s local Clinical Research Associate and/or medical monitor
• Arrange and lead meetings with U.S. PIs and medical staff in collaboration with the CRO
• Support the CRO in identification and selection of qualified investigational sites in the U.S.
• Attend annual scientific meetings and present data as applicable
• Ensure compliance with Clinical Good Practices and other applicable requirements
Clinical Support Manager (50% time)
• Enhance clinical/scientific knowledge of product through appropriate scientific exchange, publications, podium presentations and abstracts.
• Participate in medical education for healthcare professionals through presentations at office visits, investigator meetings, advisory boards, medical meetings, and other appropriate venues to enhance product and disease state knowledge.
• Collaborate with clinical team and Burn team specialists to coordinate and optimize educational and research support for sites/investigators participating in Vericel clinical trials.
• Respond to unsolicited requests regarding interest in investigator sponsored studies (ISS), and support ISS submissions through appropriate internal processes.
• Responds to unsolicited request for medical information associated with supported products and disease state areas.
-Provide clinical support for patients receiving Vericel products:
- Full engagement in and intimate knowledge of the care of burn patients from admission through discharge
- Support for various operating room procedures involving product patients, including:
- Product placements
- Dressing changes
- Other miscellaneous
• Awareness of and impact on burn centers’ evolving patient population
-Intimate knowledge of various burn product utilization protocols at facilities
• Clear understanding of product’s role(s) within these protocols
• Product use and interactions with other products
• Availability of medical supplies at key at active accounts that are compatible with product
-Train and support all appropriate staff in active accounts and select prospect accounts
-Engage with Key Opinion Leaders (KOLs) in the burn treatment field
Qualifications, Education, and Experience:
Required Education and Experience:
• Strong interpersonal, management, cross-functional and organizational skills required
• Bachelor or higher nursing degree with 3 years plus clinical experience as a burns nurse
• Pharmaceutical / Medical Device Industry experience in a relevant discipline
• Clinical research experience in the pharma / biotech / medical devices industry.
• Practical knowledge of FDA regulations on good clinical practices (GCP) required.
• Practical knowledge of International Conference on Harmonization (ICH)-GCP guidelines for clinical trials required.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Working Conditions and Physical Demands:
• Must be able and willing to travel nationally and be located within 30 miles of a major airport hub (s) on the West Coast of the United States.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.