Clinical Research Program Director

The Clinical Research Program Director serves as a senior clinical research professional and is responsible for operational and financial management and coordination of large and complex research and/or research intervention programs in collaboration with the principal investigator. The Program Director works independently and is accountable for larger programs to utilize multiple staffing levels. The Program Director demonstrates expert clinical, organizational, and communication skills and functions as a resource regarding the clinical research and/or grants process, and demonstrates expert understanding of the federal and institutional regulations and policies governing clinical research involving protection of human subjects (JCAHO, FDA, ICH, GCP, OHRP, IRB, NIH). The Program Director functions as a resource for those professionals requiring assistance and trains new staff and ensures the smooth running of the clinical research program team, including ensuring colleagues are updated on all relevant issues. This position supervises Clinical Research Managers and other project staff and oversees the day-to-day research program operations following Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, company goals and budgets. The Program Director reports to a division chief, department chair or principal investigator.

Qualifications:
Minimum Education
Master's Degree Master's degree in Clinical Research Administration, Public Health, Nursing or other related field. (Preferred)

Minimum Work Experience
5 years At least 5 years of directly related research experience with a master's degree. (Required) Or
4 years At least 4 years of relevant experience, including supervisory experience. (Required)

Required Skills/Knowledge
Knowledge of HIPAA, Federal Wide Assurance and International, Federal, State, and local rules and regulations regarding the proper conduct of human subject research is required.
Demonstrated expert understanding of the federal institutional regulations and policies governing clinical research involving protection of human subjects (ICAHO, FDA, ICH, GCP, OHRP, IRB, NIH).
Excellent interpersonal and communication skills are essential.
Ability to prioritize work in a fast-paced, complex environment with multiple and conflicting interests.
Ability to work across teams and with a variety of projects and constituencies.
Evidence of progressively increasing responsibilities.

Functional Accountabilities
Responsible Conduct of Research

• Ensure compliance with standards for the responsible conduct of research, research ethics and integrity, safety and compliance, including data security, privacy, confidentiality and human subjects protection.

• Plan, conduct, and manage research projects within the federal, local and institutional regulations, policies and procedure, guidelines and standards under the direction of the principal investigator.

• Ensure the timely filing of regulatory documents as designated by the PI and monitors compliance with relevant laws and regulations.

• Responsible for appropriate use of research funds and resources.

• Ensure compliance with all annual training requirements.

• Partner with Compliance Program staff to foster a culture of compliance and the development and implementation of action plans in preparation or response to external or internal audits.

• Maintain professional growth and development and enhance quality improvement initiatives and regulatory compliance through seminars, workshops, and professional affiliations to keep abreast of the latest trends in field of expertise.

• Designs, establishes and maintains an organizational structure and staffing to effectively accomplish the organization's goals and objectives; oversees recruitment, training, supervision and evaluation of staff.

• Directly supervises Clinical Research Program Managers, which includes direct day-to-day supervision, training, mentorship and evaluation of staff and providing coverage as needed.

• Defines, sets and utilizes appropriate performance and quality measures for the department and individual staff members.

• Demonstrates expert clinical, organizational, and communication skills and functions as resource regarding the clinical research and/or grants process.

• Functions as a resource for those professionals requiring assistance and will train new staff and ensure the smooth running of the clinical research program team including that colleagues are updated on all relevant issues.

• Facilitates interactions between team members and/or project participants; exhibits inclusive approach to decision-making and goal-setting processes, encourages participation from team members and consistently recognizes the contributions of other team members.

• Exhibits leadership skills through forming a team that possesses balanced capabilities, setting the mission, values and norms and holding team members accountable for results individually and as a whole.

• Establishes, builds and sustains professional contacts for the purpose of building networks of people with similar goals that support similar interests.

• Demonstrates ethical and professional practices and stimulates social accountability and community stewardship.

• Acts as a role model for other professionals by communicating responsively, respectfully and assertively with the research team, staff and research participants/families.

• Collaborates with physicians and other health care professionals throughout all phases of the research process.

• Contributes to the program's strategic plan including short-term and long-term objectives; monitors and evaluates programmatic and operational effectiveness and effects changes required for improvement.

• Develops systems to track multiple projects including all regulatory files, investigator and IRB information, patient recruitment activity and financial management, as well as ensuring high data quality across all clinical trials.

• Facilitates the preparation of Institutional Review Board applications for clinical research proposals, develop and manage budgets and coordinate grant applications, progress reports and regulatory documentations submissions as required by the sponsor.

• Reviews invoices and clinical research bills for accuracy; compares with operational plans, budgets, subcontracts and protocol.

• Identifies problems and opportunities and addresses them; brings appropriate problems and opportunities to leadership and facilitates discussion and deliberation.

• Compiles and analyzes data to support upper management decision-making.

• Effectively manages day-to-day research and/or research intervention program operations.

• Assumes primary responsibility for ensuring study is compliant with applicable government regulations, data access rules and privacy regulations as necessary.

• Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.

• Collaborates with Clinical Research Investigators to initiate the development of new protocols and coordinate efforts to implement Children's National Research Institute investigator-initiated trials, industry-sponsored trials and federally sponsored trials, including complex multi-disciplinary protocols that involve multifaceted collaborations with numerous entities.

• Consistently ensures timely sponsor/data center submission, IRB submission and regulatory filings by the principal investigator and study team; adheres to reporting requirements to the IRB, institutional department, sponsor and local and federal agencies.

• Collaborates with upper management to evaluate both current and new program initiatives for effectiveness, feasibility and cost.

• Demonstrates proficiency in compiling and analyzing data to support upper management decision-making.

• Ensures compliance and monitors performance of investigational sites/subcontracts for clinical studies; prepares accurate and timely visit reports from all site interaction visits.

• Leads education of and document creation for SOPs, tutorials, guidance and supplementation forms which support clinical data collection, subject recruitment, management of organizational requirements and overall efficient study conduct.

• Acts as a liaison between sponsor agencies (e.g. NIH, Foundation, pharmaceutical companies and partnering universities) and internal study team communicating study timelines and proposing and implementing solutions to problems that jeopardize the schedule or quality of studies, as directed by the principal investigator.

• Develops and monitors grant and project budgets.

• Ensures program activities and expenditures are in compliance with the terms of grants and/or granting agencies.

• Manages study team compliance with clinical research billing policies and procedures.

• Verifies appropriate clinical research billing charges.

• Monitors performance reports and evaluates budget variances.

• Develops recommendations to facilitate meeting budget requirements.

• Consistently utilizes cost effective resources and meets budget and staffing requirements.

• Incorporates budget considerations in all planning and decision making.