Clinical Research Manager - Department of Surgery

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The Clinical Research Manager serves as the primary liaison between investigators, sponsors, regulatory agencies, institutional leadership, research personnel and the institutional research office. The position ensures compliance with federal regulations, Good Clinical Practice (GCP), Institutional Review Board (IRB) requirements, and Albany Medical Center policies while promoting high-quality research operations and fiscal stewardship.

Essential Duties and Responsibilities:

Leadership and Operational Oversight

• Direct and oversee daily operations of the clinical research program.

• Develop and implement operational processes to improve efficiency, quality, and regulatory compliance.

• Monitor study progress, enrollment goals, timelines, and performance metrics.

• Serve as a resource to investigators, physicians, scientists and research staff regarding clinical research operations and requirements.

• Collaborate with departmental leadership on strategic planning and program development initiatives.

Personnel Management

• Supervise, mentor, and evaluate clinical research staff, including research coordinators, nurses, data specialists, and support personnel.

• Establish staffing plans and workload distribution to meet research program needs.

• Ensure staff maintain required certifications, training, and competency assessments.

• Foster a culture of accountability, collaboration, and continuous improvement.

Regulatory Compliance and Quality Management

• Ensure compliance with federal, state, sponsor, and institutional regulations governing human subject research.

• Maintain expertise in FDA regulations, Good Clinical Practice (GCP), HIPAA requirements, and IRB policies.

• Oversee study regulatory documentation and ensure timely submissions and approvals.

• Prepare for and coordinate internal audits, sponsor monitoring visits, and regulatory inspections.

• Implement quality assurance and quality improvement initiatives to maintain data integrity and protocol compliance.

Research Study Administration

• Oversee study startup activities including feasibility assessments, budget development, contract review, and protocol implementation.

• Monitor study milestones, recruitment efforts, and study performance indicators.

• Ensure accurate collection, management, and reporting of clinical research data.

• Support investigators in the development and implementation of investigator-initiated research projects.

• Assist with study close-out activities and final reporting requirements.

Financial Management

• Develop, monitor, and manage clinical research budgets.

• Ensure timely billing and payments.

• Monitor research expenditures, sponsor payments, invoicing, and financial reconciliation.

• Collaborate with institutional finance and grants management teams to ensure fiscal accountability.

• Identify opportunities for program growth and sustainable funding strategies.

Communication and Collaboration

• Serve as a communication link between study sponsors, investigators, institutional leadership, and research personnel.

• Represent the research program at departmental, institutional, and sponsor meetings.

• Maintain effective working relationships with internal and external stakeholders.

• Facilitate education and communication regarding research program initiatives and requirements.

Education, Licensure, and Certification Required

• Bachelor's degree in Nursing, Public Health, Health Sciences, Life Sciences, Healthcare Administration, Business Administration, or related field required.

• Master's degree preferred.

• Clinical research certification (CCRP, CCRC, CCRA, SOCRA, or equivalent) preferred.

• GCP and Human Subjects Protection training required.

Experience

• Seven (7) to ten (10) years of progressively responsible clinical research experience.

• Previous supervisory or management experience required.

• Experience managing clinical trials, regulatory compliance programs, research budgets, and multidisciplinary teams preferred.

Special Knowledge, Skills, and Abilities

• Advanced knowledge of Good Clinical Practice (GCP), FDA regulations, IRB requirements, and human subject protections.

• Strong understanding of clinical trial operations and research methodologies.

• Demonstrated leadership, organizational, and project management skills.

• Excellent verbal and written communication skills.

• Ability to manage multiple priorities in a fast-paced environment.

• Strong financial management and budgeting skills.

• Proficiency in Microsoft Office and clinical research management systems.

• Ability to establish and maintain effective working relationships across all levels of the organization.

• Ability to analyze complex problems and develop practical solutions.

We offer a highly competitive benefits package, including:

• Competitive base salary ($94,957- $147,183) commensurate with experience

• Comprehensive health insurance (medical, dental, vision).

• Generous paid time off and holiday schedule.

• Albany Med retirement plan plus a 403(b).

• Employee wellness programs and mental health support.

Thank you for your interest in Albany Med Health System!

Albany Med Health System is an equal opportunity employer.

This role may require access to information considered sensitive to Albany Med Health System, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that:

Access to information is based on a “need to know” and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Health System policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.