Clinical Trials Research Manager

3 days ago


Park Ridge, Illinois, United States Advocate Health Full time
Job Title: Clinical Trials Research Manager

Advocate Health is seeking a highly skilled Clinical Trials Research Manager to oversee clinical research, including industry and federally-sponsored clinical trials, cooperative group studies, from initiation to completion in the Oncology service line in Illinois.

The successful candidate will lead and develop a diverse team of research professionals responsible for the conduct of clinical trials research across multiple sites, including hospital and clinic settings. Key responsibilities include:

  • Developing working relationships and collaborating with clinical and research leadership to align internal strategies, enhance the institution's research capabilities and reputation, and establish best practices.
  • Partnering with leadership, research support services, and investigators to provide financial oversight related to research study budgets and trial financial performance.
  • Establishing effective, efficient, high-quality, and valued clinical trial research through quantifiable and standard metrics and working with clinical trial leadership to implement mechanisms to drive measurable performance improvement.
  • Monitoring and ensuring research is compliant with applicable regulations and policies of the research institute, the Research Subjects Protection Program (RSPP), and other related departments, programs, and governmental agencies.
  • Managing communications related to research studies, quarterly metrics, safety/compliance issues, audit findings, etc. to keep investigators and research team members informed and aligned.
  • Partnering with internal and external stakeholders to develop new business relationships to augment research opportunities.
  • Partnering with analytics, research systems, and other groups to develop, facilitate, implement, and use appropriate research systems (e.g., clinical trial management systems) to ensure efficient research operations.
  • Leading by example in creating a culture of teamwork, engagement, diversity, equity, and inclusion.
  • Performing human resources responsibilities for staff, including interviewing and selection of new employees, promotions, staff development, performance evaluations, compensation changes, resolution of employee concerns, corrective actions, terminations, and overall employee morale.
  • Developing and recommending operating and capital budgets and controlling expenditures within approved budget objectives.
  • Responsible for understanding and adhering to the organization's Code of Ethical Conduct and ensuring that personal actions and the actions of employees supervised comply with the policies, regulations, and laws applicable to the organization's business.

Requirements:

  • Clinical Research Coordinator (CCRC) certification issued by the Association of Clinical Research Professionals (ACRP) when eligible needs to be obtained within 1 year, or
  • Clinical Research Professional (CCRP) certification issued by the Society of Clinical Research Associates (SOCRA) needs to be obtained within 1 year.

Education:

  • Bachelor's Degree in Nursing, or
  • Bachelor's Degree in Health Science, or
  • Bachelor's Degree in Life Science or related field.

Experience:

  • Typically requires 5 years of experience in clinical trials research, including 3 years of management experience in leading a team. Experience in Oncology clinical trials highly desired.

Knowledge, Skills & Abilities:

  • Ability to problem solve and facilitate consensus in a group environment.
  • Knowledge of regulations and guidelines consistent with the conduct of clinical trials, including but not limited to ICH-GCP guidelines, Code of Federal Regulations, AAHRP accreditation standards.
  • Demonstrated knowledge of clinical trials business practices.
  • Effective communication and leadership skills.
  • Ability to think critically.
  • Ability to organize with attention to detail.
  • Ability to handle stress.
  • Project management skills.
  • Ability to establish and maintain successful relationships.
  • Ability to work as a member of a diverse team as well as an independent agent of change.

Physical Requirements and Working Conditions:

  • Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently during the work shift.
  • Must have functional sight and hearing.
  • Ability to function in a latex environment.
  • Will be exposed to mechanical, electrical, chemical, and radiation hazards as well as blood and body fluids on a continuous basis; therefore, protective clothing (i.e., gown, mask, goggles, gloves, etc.) must be worn as necessary.
  • Exposed to a normal office environment.
  • Operates all equipment necessary to perform the job.


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