Regional Site Liaison

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.