Sr. Research Compliance Monitoring Specialist

The Transplant Oncology and Infectious Diseases Clinical Research Center is looking for a Sr. Research Compliance Monitoring Specialist to develop and oversee the data source verification process and regulatory management of multiple clinical trials that have numerous academic centers participating in each trial. Our research focuses on solid organ transplantation and in particular, novel transplantation practices such as organ donation from donors with HIV and hepatitis C. The Sr. Compliance Monitoring Specialist will ensure the quality, accuracy and integrity of the clinical trial data and regulatory documents throughout the full life cycle of assigned clinical trials.

Specific Duties & Responsibilities

• Performs and coordinates all aspects of the remote clinical monitoring 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 identifies issues of non-compliance and/or significant deficits during the monitoring/auditing visit and communicates these findings to the Johns Hopkins Transplant Oncology and Infectious Disease Clinical Research Center (TOID CRC).
• Provides detailed site initiation, monitoring, and close-out visit reports to research teams and sponsors in a timely manner.
• Assigns data queries and works with participating sites to ensure they address data queries in a timely manner.
• Contributes to general clinical site management support as needed.
• Create and maintain Trial Master Files in compliance with ICH guidelines, ensuring the collection and maintenance of required essential documents.
• Assists in screening adverse events for seriousness and facilitates 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.
• Assists in the development and editing of Lab Manuals, Manual of Procedures, CRFs, and other study specific documents. 

• Bachelor's Degree in a related discipline.
  

• 5 years related experience.
• Additional education may substitute for some experience to the extent permitted by the JHU equivalency formula.

• Master's Degree preferred.
  

• SOCRA (CCRP) or ACRP (CCRA) certified preferred.
• Clinical trials experience; transplant/oncology patients/infectious disease.

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.

Classified Title: Sr. Compliance Monitoring Specialist 
Working Title: ​​​​​​​Sr. Research Compliance Monitoring Specialist   
Role/Level/Range: ACRP/04/MD  
Starting Salary Range: $54,080-$74,390-$94,710 Annually (Commensurate with experience) 
Employee group: Full Time 
Schedule: Monday-Friday, 8:30am-5:00pm 
Exempt Status: Exempt 
Location: ​​​​​​​Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM DOM Infectious Disease  
Personnel area: School of Medicine 

Total Rewards
The referenced salary range is based on Johns Hopkins University’s good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/

Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:

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.

**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate’s conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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

Accommodation Information

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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.

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.

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