Clinical Research Program Director

paid time off, sick time, tuition assistance, 401(k) 1 Inventa Place Silver Spring, MD 20910 Kids Are Our Everything. Department 10415 CHORDS - Research Pay Range $103,355.20 - $172,244.80 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. Minimum Education Master's Degree in Clinical Research Administration, Public Health, Nursing or other related field. (Preferred) Minimum Work Experience At least 5 years of directly related research experience with a master's degree. (Required) Or 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. Management of Human Capital and Organizational Relationships 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 #J-18808-Ljbffr Children's National Medical Center