The Center for Psychedelic and Consciousness Research is seeking a Sr. Compliance Monitoring Specialist who will take the lead on compliance monitoring and regulatory management of several clinical trials involving the administration of psychoactive substances to both healthy and patient populations. The Sr. Compliance Monitoring Specialist will ensure the quality, accuracy, and integrity of clinical trial data and regulatory documents throughout the full lifecycle of multiple clinical trials.
Specific Duties & Responsibilities
- Manage study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Participate in risk assessments by reviewing studies for quality assurance and general content.
- Develop standard and protocol-specific forms, trial-specific monitoring plans, and SOPs.
- Ensure the collection and maintenance of required essential documents.
- Assist in training new research staff regarding research compliance and regulatory documents.
- Generate monitoring summary reports and communicate these findings to Investigators and Research Staff.
- Verify that written informed consent is obtained before each subject's participation in the trial.
- Verify that source documents, other trial records, and CRFs are accurate, complete, and legible and that CRF entries reflect the source.
- Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and take appropriate action designed to prevent the recurrence of the detected deviations.
- Help study staff prepare for external audits. Participate in unscheduled internal reviews and compliance monitoring reviews on an as-needed basis.
- Educate principal investigators and/or individual coordinators regarding study procedures, regulatory requirements, and other study responsibilities.
- Other duties as assigned.
Special Knowledge, Skills, & Abilities
- Ability to work independently and exercise the judgment necessary.
- Excellent written and interpersonal communication skills and the ability to build effective relationships both internally and with outside regulatory officials (e.g. DEA, FDA).
- Knowledge of medical terminology and human subject research.
- Strong organizational, IT, and administration skills with attention to detail.
- The candidate must be proficient in Microsoft Excel and Word.
- Knowledge of IRB and FDA guidelines.
- BA/BS in medical research or scientific discipline, health care related, or other appropriate discipline preferred.
- Minimum 5 years of experience with clinical trials/medical research required.
- Certified Clinical Research Associate (CCRA) credentialing is preferred.
- Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice preferred.
Classified Title: Sr. Compliance Monitoring Specialist
Working Title: Sr. Compliance Monitoring Specialist
Starting Salary Range: $54,080-$74,390-$94,710 Annually (Commensurate with experience)
Employee group: Full Time
Schedule: Monday thru Friday 8:30 -5:00
Exempt Status: Exempt
Location: Johns Hopkins Bayview
Department name: 10003297-SOM Psy Bay Behavioral Pharm Rserch Unit
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.
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