Regional Site Liaison, Clinical Operations

6 days ago

Cambridge, United States BlueRock Therapeutics Full time
The Cambridge, MA location is seeking a highly motivated person who possess proven clinical site engagement experience in early and late phase clinical trials, to join the Clinical Operations team as a Regional Site Liaison (RSL), reporting to the Senior Director, Site and Patient Engagement. The RSL will support study teams and the broader Development organization by providing local relational and operational support to investigative site personnel, with the goal of building long-term relationships between the sites and BlueRock Therapeutics. Site territory will be US.
The RSL is responsible for providing local relational and clinical operations support to investigative site personnel and CRAs to strengthen customer relations, ensure customer satisfaction and support BRT clinical trials at the site. In this role, the RSL will serve as the primary BRT resource for sites conducting BRT clinical trials. The RSL will also be integral in helping build out globally a BRT reputation as leaders in cell+gene therapy. Responsibilities:
  • Building a global network of physician investigators in the areas of Neurology, Ophthalmology, Immunology and future therapeutic areas of interest to BlueRock.
  • Providing country/regional clinical operations expertise and local sponsor oversight of clinical sites to optimize quality and execution of BRT studies.
  • Possessing operational knowledge of the protocol and having the ability to answer site questions and/or assist connecting the site to BRT and/or CRO personnel who can.
  • Partnering with the local CRA, supporting CRA‘s relationship with site personnel and assisting with issue resolution at the site.
  • Assessing CRA/CRO performance through regular contact with the site personnel.
  • Attending/scheduling start-up and interim meetings (remote and in person) with site personnel; includes attendance at QVs, SSVs, SIVs and IMs.
  • Facilitating/conducting ‘insight sessions‘ with study coordinators and other site personnel during study/protocol planning, logistics, site and patient burden, etc. Also conduct these sessions when enrollment is behind projected timelines.
  • Monitoring site performance metrics on individual studies, e.g., training completion, start-up timelines, enrollment performance, etc., assisting the site, as necessary.
  • Developing and implementing site-level recruitment plans (or oversight of CRO development on site-level recruitment plans).
  • Conducting and completing sponsor oversight visit reports.
  • For studies including surgery, working closely with Clinical Site Liaison (CSL), facilitating their interactions with the sites to enable successful surgeries; includes assisting/attending ‘mock‘ surgical site runs.
  • Partnering with CDST and CRO on site identification, feasibility, qualification, initiation, and closeout activities
  • Providing support to BRT study teams by being the single point of contact for information exchange, issue escalation/resolution as they relate to either the CRA and/or the site.
Minimum Requirements
  • The primary goal of this position will be to build relationships with site personnel, including being responsive to their requests for information, problem solving and/or issue resolution.
  • Minimum of a Bachelors‘ degree (BS preferred) in a scientific field of study with a minimum of 4 years of relevant experience working in the clinical trial setting (i.e., either at a clinical site or in the pharmaceutical/ biotech industry) required.
  • Experience/knowledge in Neurology, Ophthalmology, Immunology preferred, with the ability to learn future therapeutic areas/disease states.
  • Ability to build and maintain strong relationships and credibility with investigative site personnel.
  • Exceptional customer service skills with excellent leadership, interpersonal and communication skills and deep understanding/appreciation of the working relationships between investigative sites, CRA/CRO and the Sponsor.
  • Have experience with site operations and be knowledgeable about the conduct and monitoring of clinical studies.
  • Have an awareness of local country requirements including necessary institutional/health authority approvals (e.g., IRBs, FDA, EMEA, etc.).
  • Possess strong organizational skills with an ability to align priorities, lead multiple tasks/activities and manage time independently.
Work Environment:
  • This position can be based remotely anywhere in the United States.
  • Up to 60% travel may be required.

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