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Clinical Research Project Manager, Regulatory Biology Laboratory, Dr. Satchidananda Panda
Salk Institute for Biological Studies
POSITION SUMMARY Coordinate all aspects of human subject research studies from initiation through study closeout. Build and maintain relationships with sponsors, collaborators, and research staff. Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, manual of operation, and progress reports. Maintain required records and ensure compliance with protocols, regulatory guidelines, and overall clinical objectives. Record adverse event and side effect data and confer with investigators regarding reporting of events to oversight agencies. Utilize project management methodologies, lead cross-functional teams, resolve issues within the clinical study, and ensure that all targets, timelines, budgets, and requirements are met. Periodically coordinate with wet-lab personnel to get biological samples processed, analyzed and results interpreted. Assist investigators in writing and submitting applications for funding.
ESSENTIAL FUNCTIONS (40%) Oversee human subject research in Panda lab and in the laboratories of lab collaborators. (30%) Oversee the functioning and upkeep of the digital platform to run human subject research. (15%) Supervise research staff; train staff, assign tasks, oversee project task completion. Coordinate with clinical nurses, dieticians, database manager, clinical analytical lab. (15%) Analyze data, prepare reports, assist in the preparation and submission of grant proposals, interim reports and manuscripts. EXPERIENCE Required:
Preferred:
EDUCATION Required
SKILLS AND ABILITIES Required
Preferred:
SPECIAL CONDITIONS OF EMPLOYMENT
PHYSICAL REQUIREMENTS This position will be constantly adjusting focus, grasping, hearing, keying, seeing, sitting, talking, analyzing, calculating, reading, reasoning, writing and working inside.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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