Program Director

Basic Function:

To coordinate and manage clinical studies and site personnel from pre-study planning through successful completion of enrollment.

Education/Skills:

Previous clinical study experience that developed the necessary skills to manage research projects is required.   Additional training in nursing or the health care industry is also recommended.

Position Responsibilities:

• Participate in proposal and contract development, including protocol assessment, budgeting and resource allocation, and interact with company clients as required to obtain sufficient information for proposal development;
• Develop and implement solutions and suggestion for improving outsourcing operational efficiency. Ensure the entire office maintains strict adherence to current protocols, resulting in protocol violations;
• Screen and manage additional coordinators and support staff as the company expands and grows;
• Explore new business opportunities.
• Supervise and manage research staff on a daily basis;
• Ensure that all employees are working at their optimum level. Hire and terminate personnel as required;
• Ensure training sessions and office audits are being completed as scheduled;
• Meet each CRA during their visit to insure coordinating responsibilities are being met. Be present during all discussions between CRAs and Principal Investigators;
• Employee evaluations, salary increases and counsel employees when required;
• Assist in pre-study planning, including preparation of critical documents, discussing logistics, and subject recruitment strategies. Attendance at pre-study meetings (site visits and initiations) and off-site investigator meetings, as required;
• Assist coordinators with daily subject visits;
• Ensure smooth subject flow during subject hours;
• Maintain and update current and upcoming trial list;
• Maintain a calendar, including site visits, study initiation visits, subject stays, monitor visits and staff scheduling;
• Assign new studies to coordinating teams;
• Attend appropriate professional meetings and review scientific and medical literature to increase research knowledge.
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Reporting Requirements:

This position reports to the Director of Research Operations.  Training and guidance will be provided through regular meetings, phone contacts and travel.  There is a high degree of autonomy in this position.  Independence in decision making and problem solving is encouraged as well as offering ideas for improving and promoting the company.