Contract Research Assistant Jobs in Oak Ridge, TN

POSITION SUMMARY: The Clinical Research Manager provides operational and clinical leadership for the Clinical Research Program and is responsible for the overall coordination, management, and growth of clinical research activities. This role oversees the daily operations of the research team while ensuring the delivery of high-quality, compliant, and patient-centered clinical trial services.

In addition to leadership responsibilities, this role is expected to maintain operational involvement in clinical research activities and provide direct support to clinical trial operations as needed. In a collaborative, growing program environment, the Clinical Research Manager must be willing to work alongside the research team and provide coverage or assistance during staffing shortages, employee absences, or periods of increased workload.

The Clinical Research Manager works collaboratively with physicians, sponsors, contract research organizations (CROs), regulatory agencies, and leadership to identify and implement scientifically sound clinical trials that expand treatment opportunities for patients. This individual will play a key role in developing program infrastructure, mentoring staff, enhancing operational efficiency, and supporting strategic growth initiatives.

This position is ideal for a mature clinical research professional with extensive oncology, neurology, or pulmonology clinical trial experience, strong leadership capabilities, and a passion for building and advancing a growing research program.

As the program continues to expand, additional growth opportunities may become available within affiliated oncology and radiation therapy services, including the potential to assist in clinical nursing and patient care initiatives that may lead to advancement into broader leadership responsibilities.

JOB RESPONSIBILITIES:

• Provide day-to-day operational oversight and leadership of the Clinical Research Program and Clinical Research Coordinators.
• Participate in day-to-day clinical research activities and assist with study coordination responsibilities as needed in support of team operations and patient care.
• Oversee the implementation and management of clinical trials from study start-up through close-out, including:

• Confidentiality Disclosure Agreements (CDAs)
• Protocol and regulatory document review
• Site qualification and pre-site visits
• IRB submissions and regulatory compliance
• Principal Investigator communication
• Budget development and contract review
• Clinical Trial Agreements (CTAs)
• Site initiation visits
• Patient screening, enrollment, accrual, and follow-up
• Informed consent process oversight
• Monitoring visits and sponsor communications
• Case report form completion and submissions
• Serious adverse event reporting and documentation

• Ensure compliance with FDA regulations, Good Clinical Practice (GCP), institutional policies, and Standard Operating Procedures (SOPs).
• Serve as a clinical and operational resource to research staff, providing mentorship, guidance, accountability, and professional development.
• Assist in the identification and evaluation of new clinical trial opportunities that align with organizational and physician strategic initiatives.
• Foster collaborative relationships with physicians, sponsors, CROs, and healthcare professionals to support program growth and study development.
• Monitor study progress, patient accrual, data quality, and operational performance metrics.
• Identify opportunities for quality improvement, workflow optimization, and program expansion.
• Assist with analysis and interpretation of clinical research data and study-related reporting.
• Effectively communicate program updates, operational concerns, staffing issues, and patient or physician-related matters to leadership with appropriate escalation as needed.
• Promote a culture of professionalism, accountability, collaboration, and patient-centered care.
• Support cross-training and operational flexibility within the research team.
• Maintain strict confidentiality of patient, sponsor, and organizational information in accordance with HIPAA and applicable regulations.

JOB EXPERIENCE AND EDUCATION:

• Bachelor’s degree required; Bachelor of Science in Nursing (BSN) strongly preferred.
• Current nursing licensure is preferred, if applicable.
• Minimum of six (6) years of progressive clinical research experience, preferably within oncology or related specialty areas.
• Prior leadership, supervisory, or program management experience are strongly preferred.
• Experience managing multiple complex clinical trials simultaneously.
• Strong working knowledge of FDA regulations, GCP guidelines, IRB processes, and clinical trial operations.
• Experience with sponsor relations, CRO interactions, budgeting, and contract review preferred.
• Demonstrated ability to lead teams, influence operational improvement, and contribute to strategic program growth.

COMPETENCIES:

• Strong leadership, organizational, and decision-making abilities
• Ability to effectively mentor, coach, and develop team members
• Excellent verbal and written communication skills
• Strong project management and problem-solving capabilities
• Ability to manage competing priorities in a fast-paced clinical environment
• High level of professionalism, emotional intelligence, and interpersonal effectiveness
• Ability to build collaborative relationships with physicians, sponsors, patients, and staff
• Strong attention to detail and commitment to regulatory compliance
• Ability to analyze, organize, and validate clinical and operational data
• Commitment to maintain confidentiality and ethical standards