Clinical Research Program Manager
3 weeks ago
**Description**
**Qualifications**
**Minimum Education**
Master's Degree Master's in Clinical Research Administration, Public Health, Nursing or other related field preferred. (preferred)
**Required Licenses and Certifications**
Certification as a Clinical Research Professional (CCRP) or equivalent required. The current certifying bodies for clinical research professionals include Society of Clinical Research Associates (SoCRA) and the Association of Clinical Research Professionals (ACRP)..
**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.
- Ensures 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 Relatonships**
- Design, establish, and maintain an organizational structure and staffing to effectively accomplish the organization's goals and objectives; oversee recruitment, training, supervision, and evaluation of staff.
- Directly supervise Clinical Research Program Managers. The management of this staff includes: direct day-to-day supervision, training, mentorship and evaluation of the staff, and providing coverage when needed.
- Define, set and utilize appropriate performance and quality measures for the department and for individual staff members.
- Facilitate interactions among team members and/or project participants; exhibit inclusive approach to decision making and goal-setting processes; encourage participation from team members; consistently recognize the contributions of other team members. Advise and mentor other project managers on approaches to resolving operational problems.
- Sees oneself as a leader of others, from forming a top team that possesses balanced capabilities to setting the mission, values and norms, as well as holding the team members accountable individually and as a group for results.
- Establish, build and sustain professional contacts for the purpose of building networks of people with similar goals that support similar interests.
- Demonstrate ethic and professional practices, as well as stimulating social accountability and community stewardship.
- Act as a role model for other professionals by communicating responsively, respectfully, and assertively with the research team, staff and research participants/families.
- Collaborate with physician and other health care professional throughout all phases of the research process.
**Department Strategic Planning**
- Contribute to the strategic plan for the program including short-term and long-term objectives, monitor and evaluate programmatic and operational effectiveness, and effect changes required for improvement.
- Identify problems and opportunities and addresses them, bring those that are appropriate to the leadership, and facilitate discussion and deliberation.
- Compile and analyze data to support upper management decision-making.
**Research Program and Project Management**
- Effectively manage day-to-day research and or research intervention program operations including.
- Assume primary responsibility for ensuring study is compliant with applicable government regulations, data access rules, and privacy regulations, as necessary.
- Ensure that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
- Along with Clinical Research Investigators initiate the development of new protocols and coordinate efforts to implement Children's Research Institute investigator-initiated trials, industry sponsored trials, and federally sponsored trials, including complex multi-disciplinary protocols that involve multifaceted collaborations with numerous entities. Assist Clinical Research Investigators with clinical protocol development, preparation and submission of research grants, study proposals, progress reports, posters, manuscripts, and abstracts.
- Consistently ensure timely sponsor/data center submission, IRB submissions and regulatory filings by the PI and study team, and adhere to reporting requirements to the IRB, institutional department, sponsor as well as local and federal agencies.
- Collaborate with upper management to evaluate current as well
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