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Clinical Research Program Director
4 months ago
**Description**
**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**
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**
- 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 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.
**Strategic Planning for Department**
- 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.
- 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.
**Research Program and Project Management**
- 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 s
