Clinical Research and Operations Manager
Norfolk, VAFull-time
Behavioral Health Market Context
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Qualifications
- •Minimum of 7 years clinical nursing experience or scientific related discipline required, preferably in oncology
- •Special knowledge of GCP and ICH guidelines
- •The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
- •Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- •Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination
- •Requires standing and walking for extensive periods of time
- •Requires corrected vision and hearing to normal range
- •4 more items(s)
Responsibilities
- •Lead and oversee clinical research operations across all research locations, ensuring compliant, high‑quality execution of clinical trials in accordance with study protocols, SOPs, Good Clinical Practice (GCP), and applicable regulatory requirements
- •Partner with physicians, research leadership, sponsors, and CROs to support trial selection, study start‑up, and successful trial execution across therapeutic areas
- •Oversee study start‑up activities, regulatory processes, and site activation timelines to support timely and efficient trial launch
- •Ensure ongoing regulatory compliance and patient safety, including oversight of protocol deviations, risk mitigation strategies, adverse event reporting, and informed consent processes
- •Provide strategic oversight of research finance activities, including budgeting, billing compliance, account reconciliation, and contract negotiations for independent trials
- •Monitor and report on key research performance metrics (e.g., enrollment, operational efficiency, trial progress) to support data‑driven decision making
- •Drive operational excellence through process improvement initiatives that enhance efficiency, consistency, and scalability of research operations
- •Recruit, develop, and lead multidisciplinary research teams, fostering a collaborative culture focused on accountability, professional growth, and high performance
- •Specific knowledge of all aspects of clinical research - ability to read, analyze and interpret technical items such as protocols, informed consent documents, and regulatory documents, ability to solve problems and implement solutions
- •Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trails
- •Basic knowledge of financial management to include budgeting and contracting, understanding of site financials including revenue cycle
- •The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job
- •Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- •Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment
- •While performing the duties of this job, the employee is regularly exposed to direct contact with patients with potential for exposure to toxic substances, medicinal preparations, and chemotherapeutic agents
- •Occasionally lifts and carries items weighing up to 40 lbs
- •13 more items(s)
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