Clinical Research Manager - Department of Surgery

Albany Medical Center•Albany, NY

11d•$94,957 - $147,183•Onsite

About The Position

The Clinical Research Manager is responsible for the overall management, coordination, and administration of clinical research activities across divisions and research programs. This position provides leadership and oversight of clinical research operations, regulatory compliance, financial management, study implementation, and personnel management to support the successful execution of clinical trials and investigator-initiated research. 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.

Requirements

Bachelor's degree in Nursing, Public Health, Health Sciences, Life Sciences, Healthcare Administration, Business Administration, or related field required.
GCP and Human Subjects Protection training required.
Seven (7) to ten (10) years of progressively responsible clinical research experience.
Previous supervisory or management experience required.

Nice To Haves

Master's degree preferred.
Clinical research certification (CCRC, CCRC, CCRA, SOCRA, or equivalent) preferred.
Experience managing clinical trials, regulatory compliance programs, research budgets, and multidisciplinary teams preferred.

Responsibilities

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.
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.
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.
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.
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.
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.