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Health Care & Medicine
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Clinical Research Program Manager
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Job Description


 Minimum Education
Master's Degree

Specific Requirements and Preferences
Master's in Clinical Research Administration, Public Health, Nursing, or other related field preferred. 

Minimum Work Experience
5- 7 Years of related experience.

Specific Requirements and Preferences
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

  1. Encourage and share new ways of making the right work easier to do
  2. Recognize and share incremental improvements in operations
  3. Promote the success of organizational and department initiatives by clearly aligning programs to the mission
Responsible Conduct of Research
  1. 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.
  2. 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.
  3. Ensures the timely filing of regulatory documents as designated by the PI and monitors compliance with relevant laws and regulations.
  4. Responsible for appropriate use of research funds and resources.
  5. Ensure compliance with all annual training requirements.
  6. 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.
  7. 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
  1. 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.
  2. 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.
  3. Define, set and utilize appropriate performance and quality measures for the department and for individual staff members.
  4. 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.
  5. 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.
  6. Establish, build and sustain professional contacts for the purpose of building networks of people with similar goals that support similar interests.
  7. Demonstrate ethic and professional practices, as well as stimulating social accountability and community stewardship.
  8. Act as a role model for other professionals by communicating responsively, respectfully, and assertively with the research team, staff and research participants/families.
  9. Collaborate with physician and other health care professional throughout all phases of the research process.
Department Strategic Planning
  1. 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.
  2. Identify problems and opportunities and addresses them, bring those that are appropriate to the leadership, and facilitate discussion and deliberation.
  3. Compile and analyze data to support upper management decision-making.
Research Program and Project Management
  1. Effectively manage day-to-day research and or research intervention program operations including.
  2. Assume primary responsibility for ensuring study is compliant with applicable government regulations, data access rules, and privacy regulations, as necessary.
  3. Ensure that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
  4. 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.
  5. 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.
  6. Collaborate with upper management to evaluate current as well as new program initiatives for effectiveness, feasibility and cost.
  7. Demonstrate proficiency in compiling and analyzing data to support upper management decision-making.
  8. Ensure compliance and monitor performance of investigational sites/subcontracts for clinical studies; prepare accurate and timely visit reports from all site interaction visits.
  9. Lead education of and document creation for SOPs, tutorials, guidance and supplementation forms which support clinical data collection, subject recruitment, organizational management of organizational requirements and overall efficient study conduct.
  10. As directed by the PI, act as liaison between Sponsor Agencies (e.g. NIH, Foundation, Pharmaceutical Companies, and Partnering Universities) and internal study team communicating study timelines, while proposing and implementing solutions to problems that jeopardize the schedule or quality of studies.
Budget and Finance Management
  1. Develop and monitor grant and project budgets.
  2. Ensure program activities and expenditures are in compliance with the terms of grants and/or granting agencies.
  3. Accountable for study team compliance with clinical research billing policies and procedures.
  4. Verify appropriate clinical research billing charges.
  5. Monitor performance reports and evaluate budget variances.
  6. Develop recommendations to facilitate meeting budget requirements.
  7. Consistently utilize cost effective resources.
  8. Consistently meet budget and staffing requirements.
  9. Incorporate budget considerations in all planning and decision making.

About Children's National Health System

Childrens National Medical Center is the only exclusive provider of pediatric care in the metropolitan Washington area and is the only freestanding childrens hospital between Philadelphia, Pittsburgh, Norfolk, and Atlanta. Serving the nations children for more than 130 years, Childrens National is a proven leader in the development and application of innovative new treatments for childhood illness and injury.

Childrens National is proudly ranked consistently among the best pediatric hospitals in America by US News & World Report.

Our Culture

Children's mission is to be preeminent in providing pediatric health care services that enhance the health and well-being of children regionally, nationally and internationally. Through leadership and innovation, Children's creates solutions to pediatric healthcare problems. Children's excels in Care, Advocacy, Research, and Education to meet the unique needs of children, adolescents and their families. Children's leadership realizes that our employees are the heart of our medical center and the soul of our mission. One of our greatest assets is the diversity of our workforce, which adds to the richness of our culture. Teamwork, dedication, and professionalism are essential values and characteristics that make our employees unique.

Childrens internationally recognized team of pediatric healthcare professionals care for more than 360,000 patients each year who come from throughout the region, nation and world. Our employees share a sense of pride and commitment to the patients and families we serve. We aspire to provide patients and their families with the highest quality of care and service in a family-centered environment. In essence, we are a team of "Great People Providing Great Care."

Nursing Students

As a nursing student, you might already be craving hands-on experience at a highly respected hospital. You may be thinking about where or with which population you want to work after graduation.

At Childrens, a world-class teaching hospital and internationally-recognized leader in pediatric health, we invite nursing students at all stages of learning to explore the real world of working in a hospital setting and experience first-hand the challenges and rewards of this career.

Internship Program

The internship program provides the novice nurse with the knowledge base and skill set needed to transition to competence in clinical nursing practice. While providing the needed skills to meet the organization goals and mission, the program provides nurses with the leadership skills to work collaboratively within a multidisciplinary team. The program bridges the gap between undergraduate education and real-life professional nursing practice, delivering state-of-the art pediatric care.

The program is offered to new graduate nurses from an accredited nursing program with a passion for children. All new graduates, with less than one-year acute care experience, are eligible to participate in the program after obtaining licensure.