Clinical Research Program Manager

Shriners Children's; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player in pediatric specialty care is seeking a Clinical Research Program Manager to lead and manage retrospective studies. This role involves overseeing research activities, ensuring compliance with regulations, and fostering interdisciplinary collaboration. The ideal candidate will have a strong background in clinical research management and excellent communication skills. Join a compassionate team that values integrity and innovation, and contribute to impactful research that enhances patient care for vulnerable pediatric populations. This position offers a supportive environment where your expertise will help shape the future of pediatric healthcare.

Benefits

Medical Coverage

Dental Coverage

Vision Coverage

403(b) Retirement Plan

Tuition Reimbursement

Flexible Spending Account

Life Insurance

Short and Long-term Disability

Pet Insurance

Paid Time Off

Qualifications

• 3+ years of clinical research experience with site and study management.
• Proficient in MS Office and regulatory compliance for clinical research.

Responsibilities

• Oversee operational management of clinical research activities.
• Ensure compliance with Good Clinical Practice and regulatory requirements.

Skills

Clinical Research Management

Federal Regulations Compliance

Data Management

MS Office Proficiency

Interdisciplinary Communication

Education

Bachelor's Degree in Clinical Research or Healthcare

Master's Degree in Clinical Research (Preferred)

Tools

OnCore

Statistical Analysis Software

Job description

Company Overview

#LI-Remote

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 evidenced 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! In addition, 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. Employees in a full-time or part-time status (40+ hours per pay period) will also be eligible for paid time off, life insurance, short term and long-term disability and the Flexible Spending Account (FSA) plans. Additional benefits available to full-time and part-time employees include tuition reimbursement, home & auto, hospitalization, critical illness, pet insurance and much more! Coverage is available to employees and their qualified dependents in accordance with the plans. Benefits may vary based on state law.

Job Overview

The Clinical Research Program Manager (CRPM) is a specialized, independent research professional who is 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’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The Retrospective Core CRPM works closely with investigators f and other research personnel to ethically review data from SHC’s vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the Retrospective Core CRPM is the system’s primary liaison among research participants, study staff, the investigator(s) and study sponsor(s), related to retrospective studies. This position’s main responsibilities are to help ensure proper study conduct and the quality of data and data safeguards for retrospective studies.

This position will provide management of the retrospective studies within the clinical research program, ensure competent and standardized staff practices, and coordinate strategies to enhance interdisciplinary communication and collaboration. the Retrospective Core CRPM is responsible for direct oversight and reporting for the CRCs working in the retrospective core.

Responsibilities

Project Management and Operations

• Accountable for the retrospective core’s research activities. Facilitates the Retrospective Core’s research projects through collaborative, timely communications and teamwork. Exhibits excellent communication and collaboration in all aspects of the retrospective research program; between the site and the sponsor; and with appropriate outside entities. Establishes and maintains collaborative relationships with all involved in clinical research operations. Fosters teamwork by respecting and valuing the contributions of all involved in the clinical research process.
• Works effectively with SHC leadership to ensure the research mission is upheld. Maintains a contemporary knowledge of clinical research regulatory requirements. Has an extensive working knowledge of the complex clinical research process, from protocol development to implementation, including experience with clinical trials. Contributes to the strategic plan for the research program including short-term and long-term objectives.
• Coordinates with other members of the Department of Research Programs regarding clinical research activities, including OnCore, audits, and regulatory compliance issues. Proactively collaborates with others in the Department of Research Programs to train and support research staff including the development of work aides, templates and guidelines, policies, and initiatives aimed at improving process and efficiency
• Provides expertise, consultation and mentorship to Retrospective Core’s staff. Serves as the primary point of contact, liaison and resource for the Retrospective Core’s staff related to research, professional development, SHC research management processes, Good Clinical Practices, regulations, and policies governing clinical research.
• Takes a leadership role in implementation of process development and improvement changes, as needed.
• Directs education and training of retrospective core clinical research staff. Assures that all key personnel or persons “engaged” in a research project have met training requirements in accordance with Federal, Institution and sponsoring agency regulations. Develops staff potential and capabilities through well-defined expectations, coaching, and evaluation of progress and performance.
• Coordinates resources and services to successfully implement and monitor progress of clinical research.
• Assures prudent utilization of all resources (fiscal, human, environmental, equipment and services) through feasibility analysis and appropriate allocation of the resources available. Develops and manages project budgets, when applicable.
• Provides support, direction, supervision and mentoring for retrospective core clinical research coordinators promoting exemplary study conduct, subject safety, and the generation of accurate and complete substantiated data within SHC’s data safeguards.
• Maintains scientific integrity, intellectual honesty, and excellence.
• Demonstrates interpersonal and professional skills, including but not limited to, professional appearance, tact, planning, punctuality, dependability and the ability to work effectively with a wide range of individuals in a diverse community. Utilizes sound rationale in recognizing actual and potential problems/issues and implements an improvement plan in a timely manner.

Study Management and Operations (Good Clinical Practice)

• Has an extensive working knowledge of the complex clinical research process, from protocol development to implementation, including experience with clinical trials.
• While collaborating with investigators, sponsors, and others in the Department of Research Programs, performs critical analysis of proposed research projects in order to determine appropriateness and feasibility at the local site, including the evaluation of resources required, budgeting, and regulatory requirements
• Contributes to the development of SHC investigator-initiated research protocols, which may include study design, development of a testable hypothesis or research questions, evaluation of resources required, budgeting, and regulatory requirements. Assists with the development and submission of grant applications and progress reports.
• Supports the implementation of approved research protocols Ensures studies are conducted in compliance with the approved protocol, Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, SHC policies and standards. Performs study-specific research activities within the bounds of professional licensure.
• Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, subject enrollment, and financial management. Actively collaborates with applicable headquarters departments, including Legal, and Compliance related to protocol reviews, IRB submissions, sponsored contracts, material transfers, data use agreements, and HIPAA compliance for projects conducted within SHC. Provides direction and education to clinical research staff on protocol-related activities. Proactively works with sites and study sponsors in order to obtain initial and continued approval of all retrospective clinical research protocols. Works closely with investigators, research leadership, research staff, study sponsor and regulatory agencies to conduct, analyze, prepare, and report the results of clinical research.

Data Management and Informatics

• Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study. Evaluates protocols under consideration for feasibility, including the process for data collection, entry, storage and reporting. Assists in the development of procedures to standardize data collection and management, including the safeguarding of data, for each protocol. Responsible for timely data collection. Ensures accurate entry of research and outcome data into secure research databases.
• Verifies data accuracy through internal quality control measures to confirm reported study data is accurate, complete, and verifiable from source documents. Provides timely responses to data queries; reviews source documents and addresses data discrepancies. Participates in timely and thorough data cleaning and database lock procedures in preparation for data analysis.
• Contributes in compiling, critically analyzing and preparing study results to share with research team. Provides input into the dissemination of research results by verifying all regulatory and compliance criteria are met, confirming that the SHC system is credited appropriately, and assisting with abstract and manuscript preparation and submission as applicable. 25%

Ethical and Participant Safety Considerations

• Exhibits leadership skills by applying the professional guidelines and code of ethics set for by Shriners Hospitals for Children and appropriate regulatory agencies related to the conduct of clinical research.
• Demonstrates knowledge of ethical standards set forth by the Belmont Report, the Nuremberg Code and the International Conference of Harmonization GCP standards. Exhibits a commitment to human subjects’ protection by providing the highest level of ethical and safety practices to protect all participants involved in research studies supported and approved by Shriners Hospitals for Children. Maintains education in human subject protection and good clinical practice principles, and applies knowledge of those ethical principles when interacting with subjects. Possesses a thorough understanding of the ethical issues involved with vulnerable pediatric populations, and identifies and Implements additional safeguards that should be in place for SHC’s vulnerable populations. Reports any concerns or issues directly to the Department of Research Programs or other appropriate departments for follow-up.
• Safeguards all participants involved in a research study supported and approved by Shriners Hospitals for Children. Maintains patient safety and privacy throughout the study. Collaborates with investigators and other research staff to mitigate risk. Protects the rights and well-being of human subjects. Confirms appropriate training and education are in place to safely perform study protocols. Adheres to and applies protocol eligibility criteria when enrolling patients. Demonstrates a clear understanding of an ethical and legally effective informed consent process. 20%

This is not an all-inclusive list of this job’s responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned.

Qualifications

Required:

• 3 yrs of clinical research experience, e.g. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance
• MS Office proficiency
• Bachelor's Degree in clinical research, science or other healthcare related field - or in lieu of degree, 5 yrs of specific job-related experience in clinical research administration

Preferred:

• Master's Degree in clinical research, science or other healthcare related field