Location: Baltimore, Maryland
Internal Number: 108164-en_US
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
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
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.
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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.
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