The Clinical Research Program Manager will serve 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. Work independently and is accountable for larger programs that utilize multiple staffing levels. Supervise 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) and regulatory guidelines, company goals, and budgets. Demonstrate expert clinical, organizational, and communication skills and functions as resource regarding the clinical research and/or grants process. Demonstrate 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). Function as a resource for those professionals requiring assistance and trains new staff. Ensure the smooth running of the clinical research program team including that colleagues are updated on all relevant issues, 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. Facilitate the preparation of Institutional Review Board applications for clinical research proposals, develop and manage budgets and coordinates grant applications, progress reports and regulatory documentations submissions as required by the sponsor. Responsible for review of invoices and clinical research bills for accuracy compared operational plans, budgets, subcontracts and protocol.

Minimum Education

Master's Degree Master's in Clinical Research Administration, Public Health, Nursing, or other related field 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

* 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.

* 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 as new program initiatives for effectiveness, feasibility and cost.

* Demonstrate proficiency in compiling and analyzing data to support upper management decision-making.

* Ensure compliance and monitor performance of investigational sites/subcontracts for clinical studies; prepare accurate and timely visit reports from all site interaction visits.

* 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.

* 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

* Develop and monitor grant and project budgets.

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

* Accountable for study team compliance with clinical research billing policies and procedures.

* Verify appropriate clinical research billing charges.

* Monitor performance reports and evaluate budget variances.

* Develop recommendations to facilitate meeting budget requirements.

* Consistently utilize cost effective resources.

* Consistently meet budget and staffing requirements.

* Incorporate budget considerations in all planning and decision making.