Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.
This Clinical Trial Liaison role is responsible for maximizing site performance and site engagement in clinical studies. Leveraging strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support execution of clinical studies.
Responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory requirements. Engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high quality investigative sites to support clinical development programs. Collaborate with internal and external stakeholders as well as third party vendors. Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance. Evaluate, screen and develop high quality investigative sites to support clinical development programs.
The position reports to the Sr Director, Patient & Clinical Trial Engagement
Essential Duties & Responsibilities:
Site Engagement Deliverables:
- Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stakeholders throughout the life cycle of clinical trials
- Support the clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial roadblocks, and using motivational tactics to ensure the timely delivery of trials
- Engage, evaluate, and develop a network of high-performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of its activities thereby increasing their desire to partner with ProKidney
- Develop & maintain relationships with site engagement organizations; assist identification of high-performing sites and key opinion leaders that can contribute to forums, boards and/or discussions.
- Interact/train new investigators to work on clinical trials ensuring the clinical and scientific understanding of the trial
- Support site with enrollment, including the development of patient material, advertisement materials, new requests for concierge services for participants (including travel/accommodation/appreciation items)
- Serve as primary contact for biopsy and/or procedure injections scheduling, logistics and troubleshooting.
- Support site with screen failures during the enrollment phase, including pre-screening activities to improve patient selection and trial readiness
Monitoring Deliverables:
- Responsible for attending Site Initiation Visits and managing the sites' performance regarding protocol and procedure knowledge and support
- Acts as the primary contact for the site regarding the general organization of the study, timelines, status, educational needs, and process flows.
- Responsible for the early engagement with Key Opinion Leaders (KOLs)/sites/patients organizations and key contact points for these throughout the study.
- Interact/train new investigators to work on clinical trials.
- Attend key therapeutic training/meetings and/or industry training.
- Close collaboration and partnership with CRO to inform of all aspects of the clinical trial status at the site.
- Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
- Support the development of presentations at Investigator Meetings or other trial-related meetings.
- Contributes to updates of clinical program information, e.g., annual safety updates, Investigator's Brochure, and on query resolution, as needed, etc.
- In collaboration with CPM/study team, ensure that the study is audit/inspection ready and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.
Minimum Qualifications: Education/Training: - Bachelor's Degree required. Preferably in life/physical sciences, RN or clinical degree highly preferred.
- Experience:
- Experience working in renal therapeutic area required
- Strong scientific background with at least 5 years of experience in Clinical Operations, Clinical Development, or as a Clinical Trial Liaison or Medical Science Liaison.
- Strong understanding of start-up activities, clinical trial planning, (site) management, and metrics.
- Strong communication and leadership skills.
- Field-based position, fully remote with domestic travel required 50%-75% of the time to sites within assigned territory
- Travel required to Boston and Raleigh HQs for team meetings as needed
Skills:
- Bilingual – fluent in Spanish highly preferred
ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.
