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Offer: Compliance Monitoring Program Manager:Johns Hopkins University

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Compliance Monitoring Program Manager

Johns Hopkins University

January 13, 2018
Job location:
Baltimore, Maryland

Project/Program Management/Planning, Staff/Administrative


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 everyday 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.

   » 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 all over 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 continuing 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 expertise, Skills, or Abilities / Competencies:
   » expertise of the rules governing human subjects research required.
   » Excellent organizational and interpersonal skills required.
   » capability to work independently and exercise judgment required.
   » Must have exceptional oral and written communication skills and expertise of medical terminology.
   » Excellent attention to detail skills required
   » capability to manage multiple and competing priorities
   » expertise of clinical research practices and principles required
   » Must have excellent time management skills

Specific Requirements:
   » 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 tasks and responsibilities performed on a regular and consistent basis by the incumbent(s).
   » Information technology should not be held to exclude other tasks not mentioned that are similar in nature and level of difficulty.

Appropriate qualifications:
BA/BS in medical research, health care related or other appropriate discipline required and five years practice with clinical trials/medical research. practice with quality assurance, clinical trial auditing/monitoring, and/or good clinical practice and skills with IBM-PC operation and software applications required.

Masters degree in related discipline,three years managery practice and clinical research certification isstrongly desired.

function/Level/Range: ACRP/4/ME
income: Commensurate with practice
Status: Full-Time
Work Schedule/Hours: Monday-Friday/8:30-5:00pm/37.5
Department: Oncology
Job location: East Baltimore

The prosperous 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, Contact Us by the HR Business Services Office at E-Mail: 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 continuing 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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About Johns Hopkins University
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to lgain but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130... years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses all over the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are located at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Baltimore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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Job Location:  Baltimore, Maryland
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Post Date: 01/13/2018 / Viewed 9 times
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