Clinical Research Programs Leader

Albany Med; City of Albany (NY); On-site; USD 95,000 - 147,000; Full time

Benefits offered by this job

Competitive base salary

Comprehensive health insurance

Paid time off

Albany Med retirement plan

Employee wellness programs

Job summary

Albany Medical Center is seeking a Clinical Research Manager in Surgery Administration to lead the clinical research program, ensure regulatory compliance, and manage budgets. You will coordinate multidisciplinary teams, oversee study start-up and reporting, and drive process improvements to support high-quality investigator-initiated and sponsored trials.

The role requires 7–10 years of experience, supervisory background, and strong knowledge of GCP and FDA regulations.

Qualifications

• Seven to ten 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.
• Advanced knowledge of 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.

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.

Skills

Leadership

Regulatory Compliance

Budgeting

Communication

Project Management

GCP knowledge

IRB knowledge

Staff supervision

Education

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

Master's degree preferred

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

GCP and Human Subjects Protection training required

Tools

Microsoft Office

Clinical research management systems

Job description

Albany Medical Center is seeking a Clinical Research Manager in Surgery Administration to lead the clinical research program, ensure regulatory compliance, and manage budgets. You will coordinate multidisciplinary teams, oversee study start-up and reporting, and drive process improvements to support high-quality investigator-initiated and sponsored trials.

The role requires 7–10 years of experience, supervisory background, and strong knowledge of GCP and FDA regulations.