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Clinical Research and CME Manager

Arlington Heights, Illinois

Post Date: 07/05/2017 Job ID: 1562 Job Category: Healthcare: Clinical Operations

Reporting to the Vice President, Chief Quality Officer, the manager is responsible for the day – to – day operations of the Clinical Research and Continuing Medical Education Department. Provides expert guidance and facilitation of research and CME activities and promotes the expansion/growth of the programs.

Job Responsibilities:

Clinical Research Program
  • Responsible for the overall direction and oversees the daily operations, strategic planning and continued growth of the clinical research department, as well as responsibility for financial oversight of department.
  • Manages the study review and approval Process for the company, including assessment of all study-related documents (protocol, consent form(s), risk assessment form, IRB application, Company application), and coordinates with research financial personnel for the development of budgets for hospital charges to Principal Investigators. Works with Grants & Contract Specialist to ensure that study-related contracts are consistent with the protocol and with all study operational details
  • Is responsible for leading the research credentialing process for all applicants and for insuring timely completion of the credentialing process.
  • Leads or participates in the clinical research education programs to educate investigators, nurses, and other research team members and support personnel.
  • Maintains an updated and accurate Research Database, and insures that standard reports are completed and disseminated on schedule.
  • Works with the Vice President to trouble-shoot and resolve internal compliance issues or questions pertaining to human subject research, including highly-confidential investigations.
  • Maintains and updates the Federal wide Assurance with the Office of Human Research Protections, DHHS. Ensures that IRBs are registered on the Federal wide Assurances or that a Single Use Authorization is executed.
  • In conjunction with the VP/Chief Quality Officer, assists in developing strategic operational goals, initiatives, and programs that are aligned with hospital objectives, and business development plans. Prepares monthly activity reports.
  • Promotes individual professional growth and development by meeting requirements for mandatory/continuing education, skills competency, supports department-based goals which contribute to the success of the organization; serves as preceptor, mentor, and resource to less experienced staff.

CME Program
  • Manages the day-to-day activities related to all AMA PRA Category 1 CME activities planned by the CME office. Maintains accurate financial records relating to all CME expenditures.
  • Works with the Education Committee Chairman to ensure compliance with ISMS Essential Areas, Elements and Guidelines for all CME activities.
  • Completes comprehensive educational grant applications from pharmaceutical companies and outside organizations. Collaborates with Marketing, physicians and/or outside vendors to design, review and distribute promotional materials. Serves as point-person for all Audience Response System presentations.
  • Maintains accurate financial records and oversees CME tracking systems. Prepares agendas, attends meetings, records and transcribes quarterly Education Committee meeting minutes. Compiles the annual report of CME activities for the ISMS and the Medical Executive Committee. Networks with other CME providers to learn of “ best practices” that can be implemented to improve the overall process of CME activities.
  • Adheres to all Hospital standards, policies, and procedures.

Qualifications/ Requirements:
  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (ie, registered nurse).
  • 3 - 5 years of clinical research experience required, including at least 2 years’ experience in clinical trial management
  • Experience with clinical trial planning, (site) management and metrics
  • A solid understanding of FDA regulations on Good Clinical Practice, Declaration of Helsinki, and International Conference on Harmonization requirements. Knowledgeable of relevant FDA, NIH, CMS, OHRP, HIPAA and other clinical research and human subject regulations and guidelines. Able to interpret regulations for appropriate operational implementation for all types of research studies (retrospective chart reviews, observational, registry, interventional, IND or IDE or Compassionate Use).
  • Experience managing CME activities according to ACCME and/or ISMS policies preferred.
  • Licenses/Certifications: Clinical Research Coordinator (CRC), Certified Clinical Research Professional (CCRP), Certified IRB Professional (CIP), or Certified in Healthcare Research Compliance (CHRC) preferred.
  • The interpersonal skills necessary to interact effectively with all levels of staff, physicians, external contacts and patients.
  • Excellent verbal and written communication skills necessary to prepare, develop and present information in a clear and concise manner.
  • The leadership skills necessary to delegate appropriately and direct research activity of staff to effectively motivate and maximize staff performance.
  • The analytical and problem solving skills to do financial and budget planning.
  • Organizational skills to manage multiple tasks as they relate to research trials.
  • Excellent time management skills
  • Mathematical skills to do financial planning.

Colleen Eddy
Senior Recruiter

Colleen brings high energy and a focus on service to her role as Senior Executive Recruiter at The Steely Group. She believes regard for others begins by actively listening to understand which, in turn, builds trust (the bedrock of relationships). Throughout her distinguished career, Colleen has demonstrated success developing talent; building, leading and managing teams; recruiting, training and mentoring executives; and helping employees embrace change and achieve goals.
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