The Department of Oncology is looking to hire a Full Time Compliance Monitoring Program Manager. Under the supervision of the Director Clinical Research Administration, the Compliance Monitoring Program Manager is responsible for the daily management of the Clinical Research Quality Assurance program in the Cancer Center. The individual assures the timely completion and accurate reporting of audits and trial monitoring within the Center.
DUTIES AND RESPONSIBILITIES
Develop policies and procedures, within the framework of the University and Center, appropriate to the efficient management of the clinical research audit program and trial monitoring activities, considering all Center and divisional goals.
Ensure that all Federal/State, GCP and Institutional standards are followed throughout the Center and assist in the Center wide implementation for new Federal/State and Institutional guidelines.
Manage the day-to-day operations of the Quality Assurance group in the Clinical Research Office.
Identify and assign specific clinical trials for auditing and/or monitoring by the QA Specialists. Electronically track time lines for audits and monitoring visits. Maintain a comprehensive database of all audit and monitoring results. Prepare and present quarterly statistical and billing reports for the QA program.
Design templates for audit forms, reports, locating letters and other correspondence related to the QA program. Develop standard forms and create templates for the CRO QA office with departmental input.
Act as liaison between all Government agencies such as the NCI and FDA, drug companies and clinical trials monitoring services with regards to external audits and research quality assurance issues.
Monitor studies for data integrity. Generate queries and conduct follow-up for non-compliance issues. Maintain monitoring results in a database generate monitoring summary reports and communicate these findings to Investigators, Research Staff, and Data and Safety Monitoring Committee (DSMC). Provide support for monitored trials in the form of research into regulations and review of protocols and CRF templates for protocol staff. Develop standard and protocol specific forms and SOP's
Perform audits on identified clinical trials. Develop protocol specific auditing forms. Audit research and medical records against clinical protocols for compliance. Prepare written summary of audit results. Meet with principal investigators, research nurses and data support staff to review audit results. Present findings to the DSMC and follow-up on audit results as necessary.
Serve as a member of the Clinical Research Review Pre-Review Committee. Review new protocols for quality assurance and general content. Attend Clinical Research Review Committee (CRC) as necessary. Generate Quality Assurance Summaries for CRC annual scientific reviews.
Coordinate the monthly Data and Safety Monitoring Committee meetings. Prepare agendas, track voting, and maintain meeting minutes.
Act as a resource for faculty and staff for information relating to effective data management. Assist with orientation and training of new data managers and CRO staff.
Assist with the development and presentation of educational training programs for data support staff. Teach modules as assigned for the SKCCC Clinical Research Orientation Course. Educate investigators regarding the CRO monitoring and auditing program through presentations to departmental groups and/or individual faculty meetings.
Responsible for identifying staffing needs for the QA program. Has hire, fire, performance review, and disciplinary action authority for the QA Specialists. Provide orientation and training for new QA staff as well as ongoing training for current staff.
Provide guidance to staff for preparation of external audits. Participate in unscheduled internal reviews and audits at affiliate institutions on an as needed basis.
Coordinate, develop and maintain Standard Operating Procedures for the Research Manual on the CRO website.
Coordinate, develop, and implement documents and tools to meet research standards for both Research and Clinical Nurses.
Assist Clinical Research Compliance Manager with special projects as required
Represent CRO at weekly Research Program meetings attended by entire research program staff to act as a resource for regulatory and institutional issues.
Special Knowledge, Skills, or Abilities / Competencies:
Knowledge of the rules governing human subjects research required.
Excellent organizational and interpersonal skills required.
Ability to work independently and exercise judgment required.
Must have exceptional oral and written communication skills and knowledge of medical terminology.
Excellent attention to detail skills required
Ability to manage multiple and competing priorities
Knowledge of clinical research practices and principles required
Must have excellent time management skills
Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s).
It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
BA/BS in medical research, health care related or other appropriate discipline required and five years experience with clinical trials/medical research. Experience with quality assurance, clinical trial auditing/monitoring, and/or good clinical practice and expertise with IBM-PC operation and software applications required.
Masters degree in related discipline, three years supervisory experience and clinical research certification is strongly desired.
Salary: Commensurate with Experience
Work Schedule/Hours: Monday-Friday/8:30-5:00pm/37.5
Location: East Baltimore
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at firstname.lastname@example.org. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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