Sr. Compliance Monitoring Specialist

Location
Maryland, United States
Salary
Salary Not Specified
Posted
Jul 07, 2021
Employment Type
Full Time
Johns Hopkins School of Medicine seeks aSenior Compliance Monitoring Specialist who will develop and implement a performance-monitoring plan of the clinical sites participating in trials, with respect to regulatory/protocol compliance, and data quality. This position is also responsible for developing and implementing site training content for all newly assigned trails, as well as designing training content for sites that may require remedial support. Additional responsibilities include managing multiple clinical and regulatory studies as well as administrative, regulatory, and operations support for the program. This role requires the ability to work well within a diverse group of practitioners and researchers, meticulous precision in the documentation of clinical data, strict adherence to regulatory requirements, and comprehensive knowledge of multiple research studies, ability to conduct complicated study subject visits, and the flexibility and proficiency to handle multiple tasks simultaneously. This position requires overnight travel within the United States.

Specific Duties & Responsibilities:

  • Performs and coordinates all aspects of the onsite and remote clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, HIV Organ Policy Equity Act Safeguards, local regulations, and Johns Hopkins School of Medicine Standard Operating Procedures.
  • Independently identify issues of non-compliance and/or significant deficits during the monitoring/auditing visits and communicates these findings to the Johns Hopkins Transplant Oncology and Infectious Disease Coordinating Center (TOID CRC).
  • Assists participating centers with the development of, and provides oversight for, corrective and preventative action plans of centers identified to have significant negative findings from these audits.
  • Provide detailed site initiation, monitoring, and close-out visit reports to research teams and sponsors in a timely manner.
  • Assign data queries and work with participating sites to ensure they address data queries in a timely manner.
  • Work with participating sites and the TOID CRC data management or other organizations, as requested, to resolve data queries.
  • Coordinates necessary activities required to set up, monitor, and closeout of clinical trial sites.
  • Monitor recruitment of participants and provide guidance and strategies with site team members to enhance recruitment.
  • Contribute to general clinical site management support as needed, including providing support directly with participating centers for data completion with new and inexperienced sites conducting clinical research.
  • Assist in screening adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported appropriately to sponsor and participating site IRBS within specific reporting time frames.
  • Responds to company, Sponsor, and applicable regulatory requirements/audits/inspections.
  • Assist participating site study staff to prepare for external audits. Conduct unscheduled internal reviews and compliance monitoring reviews at participating centers as needed.
  • Develop and maintain standards of efficient monitoring practices.
  • Contributes to the development of and implements protocols and informed consents for research studies.
  • Independently coordinate the development, procurement, and updating of materials (IE, study-specific lab manuals, manual of procedures and training, slides, case report forms) for assigned studies.
  • Prepare and interpret database-generated reports as part of the monitoring process, reporting to regulatory agencies, and data safety monitoring boards.
  • Act as a liaison for the studies involving the health care team, other institutions, and outside organizations.
  • Create and maintain Trial Master Files in compliance with ICH guidelines.
  • Participates in providing 24/7 pager support to participating centers. Approximately 1 week per month.
  • Initiates and maintains relationships with study collaborators, including but not limited to, site principal investigators, and site study coordinators, including coordinating any relevant training meetings.

Minimum Qualifications (Mandatory):

    BA/BS in a related discipline. Five years related experience. Additional education may substitute for some experience to the extent permitted by the JHU equivalency formula. Hospital clinical research; transplant/oncology patients/infectious.

Preferred Qualifications:

    Master’s degree. SOCRA (CCRP) or ACRP (CCRA) certified.

Special Knowledge, Skills & Abilities:

    Knowledge of Good Clinical Practices (GCP) and Good Documentation Practices. Knowledge of ICH and local regulatory authority regulations regarding clinical research. Ability to work in a fast-paced research environment, and to plan and manage multiple priorities on different timelines. Able to adapt to diverse educational and multi-cultural backgrounds. Excellent organization, time and project management skills with strong communication and interpersonal skills. Strong organizational, Information Technology, and administration skills with proficiency in Microsoft Office Suite.

JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Classified Title: Sr. Compliance Monitoring Specialist

Role/Level/Range: ACRP/04/MD
Starting Salary Range: $52,495 - $72,210 annually (commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30-5pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: ​​​​​​​SOM DOM Infectious Disease
Personnel area: School of Medicine

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 atjhurecruitment@jhu.edu. 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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

School of Medicine - East Baltimore Campus


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 jhurecruitment@jhu.edu. 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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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