Clinical Research Program Manager

Shriners Children’s Hospital; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Clinical Research Program Manager to lead and manage retrospective studies within a vibrant clinical research program. In this pivotal role, you'll ensure compliance with ethical standards and regulations while fostering collaboration among interdisciplinary teams. Your expertise will guide the operational management of clinical research activities, ensuring data integrity and participant safety. This position offers an opportunity to make a significant impact on pediatric specialty care through innovative research practices. Join a compassionate organization dedicated to excellence in patient care and research.

Benefits

Medical Coverage

Dental Coverage

Vision Coverage

403(b) Retirement Plan

Paid Time Off

Life Insurance

Disability Plans

Tuition Reimbursement

Qualifications

• 3 years of clinical research experience including site and study management.
• Proficiency in MS Office and knowledge of clinical research regulations.

Responsibilities

• Oversee clinical research activities ensuring compliance with GCP and regulations.
• Coordinate data collection and analysis, ensuring data accuracy and integrity.

Skills

Clinical Research Management

Data Management

Project Management

Regulatory Compliance

Mentorship

MS Office Proficiency

Education

Bachelor's Degree in Clinical Research or Healthcare

Master's Degree in Relevant Field

Job description

Join to apply for the Clinical Research Program Manager role at Shriners Children's.

Shriners Children’s is an organization that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidence-based practice, experience, innovation, and critical thinking. Our compassion, integrity, accountability, and resilience define us as leaders in pediatric specialty care for our children and their families.

All employees are eligible for medical, dental, and vision coverage on their first day! Additionally, upon hire, all employees are eligible for a 403(b) and Roth 403(b) Retirement Saving Plan with matching contributions of up to 6% after one year of service. Benefits include paid time off, life insurance, disability plans, FSA, tuition reimbursement, and more, with coverage for employees and dependents as per plans and state law.

The Clinical Research Program Manager (CRPM) is a specialized, independent research professional responsible for operational management, overseeing all local SHC clinical research activities. Reporting to the Research Programs Office at SHC International Headquarters, the CRPM provides support and leadership in accordance with SHC policies, hospital regulations, CFR, and GCP guidelines. The Retrospective Core CRPM works closely with investigators and research personnel to ethically review data from SHC’s vulnerable pediatric subjects and to collect and safeguard data. The main responsibilities include ensuring proper study conduct and data quality for retrospective studies.

This position manages retrospective studies within the clinical research program, ensures staff practices are standardized, and coordinates interdisciplinary communication. The CRPM oversees and reports on the work of the retrospective research coordinators.

Project Management and Operations

• Accountable for the retrospective core’s research activities, facilitating research projects through collaboration and communication. Maintains relationships with all involved in clinical research operations, fostering teamwork and respect.
• Works with SHC leadership to uphold the research mission. Maintains knowledge of clinical research regulations and processes, contributing to strategic planning.
• Coordinates with the Department of Research Programs on clinical activities, audits, and compliance. Supports staff training and process improvements.
• Provides mentorship to staff, ensuring training requirements are met. Develops staff capabilities through coaching and evaluation.
• Manages resources, including budgets, and ensures efficient utilization.
• Supports and mentors clinical research coordinators to promote exemplary conduct and data integrity.

Study Management and Operations

• Possesses extensive knowledge of the clinical research process. Evaluates research proposals for feasibility, resource needs, and regulatory compliance.
• Assists in protocol development, grant applications, and research implementation, ensuring compliance with GCP and regulations.
• Tracks project details, collaborates with legal and compliance departments, and supports study conduct and reporting.

Data Management and Informatics

• Coordinates data collection, analysis, and reporting. Ensures data accuracy, manages databases, and contributes to dissemination of results.

Ethical and Participant Safety Considerations

• Demonstrates leadership in ethical standards and human subject protection. Maintains education on ethical principles and safeguards participant rights and safety.

This list is not exhaustive; additional duties may be assigned.

Minimum Requirements

• 3 years of clinical research experience, including site management, study management, IRBs, and federal regulations.
• Proficiency in MS Office.
• Bachelor's Degree in clinical research, science, or healthcare-related field, or 5 years of relevant experience in lieu of degree.

Preferred Qualifications

• Master's Degree in relevant field preferred.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Project Management and IT
• Industry: Hospitals and Health Care