Clinical Development Liaison/Officer (CRA / Senior CRA)
Purpose: The purpose of the Clinical Development Liaison role is to responsiblefor providing operational expertise to customers through ownership ofsite feasibility and management of site performance to plan.The CDL isresponsible for new sites-prospecting, for site identification and siteevaluation. The CDL is also responsible for developing and managinginstitutional and key investigator relationships (innovation andleverage of relationship) by serving as the primary interface betweenLilly, the investigator and the vendor representatives. Responsibilities: Business Development Identify, screen, evaluate and develop investigators for clinicaltrial participation Develop and maintain relationships with major institutions Develop new sites Provide input to study manager on protocol and enrollment feasibilityfor studies Partner with study manager on the design and contribute to thestrategy of clinical study protocols Attend key therapeutic meetings, departmental education/businessupdates and other forms of technical and non-technical training Maintain technical expertise within a therapeutic area to engage inscientific discussions with the investigator and institution personnel Support Country Study Manager (CSM) on Final Patient Allocation (FPA)process Negotiate budgets and contracts with institutions and investigatorswith an emphasis on usage of standard agreements and Fair Market Value(FMV)
Business Management Primary interface with investigators Manage the link between site and the Third Party Organization (TPO) Single point of contact for institutions to identify and resolvebusiness process barriers Drive key/critical site level patient allocation Responsible for site specific enrollement and first patient visit Interact and influence the development and implementation of siteinitiation/enrollment risk plans for clinical trials Collaborate with Lilly partners, Quality, and other study team membersto resolve/escalate site specific issues when necessary Effectively understand and use resources to resolve investigator needs Apply broad clinical research knowledge to impact strategy and process Understanding of drivers that run the business and how other areas ofthe business are affected Leverage strategic knowledge of institution’s decision making processand deliver mutually acceptable business solutions If applicable, involvement/oversight of fully outsourced trials
External Influence Develop and maintain relationships with major therapeutic institutions Maintain active relationships and/or memberships with applicableresearch and disease-state organizations Influence and challenge internal and external environmental factorsthat impact clinical research strategy
Communication/Information Management Serve as primary point of contact for site personnel relative tobusiness related issues Actively listen and respond to customer needs Serve as an effective communication “bridge” between ourcustomer/partners and Lilly Coordinate, communicate, develop best practices, and buildrelationships using cross-functional teamwork
Compliance Responsible for understanding and complying with all regulatoryrequirements Responsibilities include understanding and following all compliance,procurement, legal, financial and Global Medical Standards andProcedures Maintain familiarity with regulations and guidelines regarding patientenrollment practices Responsible for the initiation and evaluation of Anit-Corruption DueDiligence (ACDD) with inverstigators Provide audit and inspection support Minimum Qualification Requirements: Demonstrated success in effective interpersonal and communicationskills Demonstrated strong leadership, teamwork, and influence are necessary Experience in professional networking with positive mutuallybeneficial outcomes Demonstrated negotiation skills Strong medical knowledge in the respective therapeutic area Strong problem-solving skills, including stractegic and creativethinking Experience and success in self-managing priorities and multi-taskingprojects Travel required Excelllent oral and written communication skills Fluent in English Other Information/Additional Preferences: Bachelor’s degree or equivalent work experience in a scientific orhealth-related field Preferably at least 2 years previous work experience in ClinicalTrial/Development experience and good working knowledge of ClinicalResearch Process Computer skills (e.g. Excel, Word, PowerPoint).