Clinical Research Associate - Pharmaceutical Clinical Associates, LLC

Position Description

Summary:
Provide expertise and project support (from initial study concept through FDA submission) in order to accomplish clinical studies on one or more drug development projects. Build relationships and effectively communicate ideas and results throughout a broad spectrum of organizational functions.

Essential duties/responsibilities:
Under the direction of the CRA II, Sr CRA, or other appropriate team member, the following activities will take place:
• participate in selection of study sites
• Coordinate activities related to multi-center investigator meetings
• Conduct site initiation visits, monitoring and close out visits
• Assure timely and appropriate involvement of critical support staff
• Track progress of project related intra-and inter departmental tasks
• Assure adherence to timelines for operational task accomplishment
• Coordinate, monitor and manage the integration of CRO services as necessary
• Participate in preparation of CRF and protocol development
• Coordinate preparation of Trial Master File
• Coordinate tracking and deployment of grant-in-aid funds
• Close out study
• Write/prepare reports related to study
• Compile submission documents
• Establish, develop, and maintain efficient communications network among internal resources, and external partners (sites, CROs, SMOs)
• Prepare project status reports for management review
• Act as a conduit of information from medical, biometrics to sites and outside vendors
• Participate in development of data management plan
• Continually review and update role and responsibilities in light of changing business needs
• Identify development opportunities and create and implement plans to address such opportunities
• Share findings, learning and expertise with other staff members as appropriate

Education/Experience:
• BA/BS degree in science or nursing field preferred
• 6-18 months of experience

Other Skills:
• Strong computer skills. Excellent oral and writter communication skills. Ability to successfully integrate groups or individuals to resolve project issues. Demonstrate ability to integrate new technologies into operational processes.

How to Apply

Application Instructions / Send a Resume