Sr. Research Program Coordinator
The Department of Radiology seeks a Senior Research Program Coordinator
who will have duties and responsibilities related to Nuclear Medicine Clinical Research. The position will work closely with the FDA for IND studies including IND submission, maintenance, and protocol writing, support the conduct of Nuclear Medicine Division Clinical Trials, and oversees the administrative and scientific implementation of clinical research. This position will be responsible for developing Standard Operating Procedures, assuring the quality of regulatory and financial management of clinical trials, facilitating study activation and investigator-initiated trial operations, and contributing to protocol and study manual development. This requires a high level of knowledge, oversight, and organization, and will serve as a central resource for faculty conducting clinical research. Responsibilities will also include orienting and training research staff in the program and assisting with general operations of the program. This position will work closely with members of the Nuclear Medicine Division Clinical Trials, including principal investigators PIs, research nurses, study coordinators, program manager, and financial manager. Specific Duties & Responsibilities:
Minimum Qualifications (Mandatory):
- Work closely with the FDA for IND studies including IND submission, maintenance, and protocol writing. Assist regulatory specialists with informed consents and protocol amendments for investigator-initiated studies, as needed. Analyze data associated with clinical trials, as needed by the division.
- Oversee the protocol approval process and maintain regulatory compliance within the Program. Assist with protocol development and revision of investigator-initiated studies.
- Work closely with principal investigator and program manager on protocol development and revision of investigator-initiated studies; assure protocols, amendments, consent forms, and study operation manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
- Responsible for the recruitment, training and supervision of research data management and regulatory personnel within the division.
- Oversee the protocol approval process and maintain regulatory compliance.
- Work with research coordinators, inpatient/outpatient nurses, research nurses, research pharmacy, and other research cores to optimize the practical implementation of protocols.
- Ensure research staff maintain complete and accurate research data and charts in a real time basis and are well prepared for auditing and monitoring visits
- Initiate and conduct meetings and other research activities with sponsors of clinical trials as needed
- Actively participate in implementing the Clinical Research Management System (CRMS) within the Program
- Develop and implement quality assurance practices for all research protocols conducted in the Nuclear Medicine Division, including routine regulatory monitoring, financial reconciliation, and staff education.
- Perform internal regulatory and/or data monitoring for investigator-initiated clinical trials; review monitoring reports conducted by industry-sponsors or outside institutions; problem-solve and implement corrective action plans as needed.
- Review and reconcile internal and external billing resulted from clinical research activities, such as service core charges, hospital and profee charges, sponsor invoicing, and study site payments (for multicenter clinical trials).
- Facilitate the full cycle of clinical research operations: development, regulatory and contract approval, interaction with Cancer Center Cores, study conduct, event reporting, quality assurance, and abstract and manuscript preparation.
- Assist with training research data management and regulatory personnel within the Program.
- Assist with clinical trials operations: provide suggestions for improved procedures, create checklists and program-related SOPs.
- Maintain a continued high level of expertise in institutional databases including Epic, CRMS, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
- Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines.
- Bachelor's degree in Biological/Social Sciences or other related discipline required.
- 3 years related experience. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Special Knowledge, Skills & Abilities:
- Master's preferred.
- 5 years experience in complex and detailed clinical trials/medical research.
- Proficiency in the use of software applications, databases, spreadsheets, and word processing required
- Highly effective verbal and written communication skills, and highly developed interpersonal skills required
- Must be able to independently assimilate and evaluate clinical research data
- Must have working knowledge of IRB & FDA reporting requirements
- Knowledge of research methodology and working knowledge of computers required
- Knowledge of clinical research practices and principles required
- Knowledge of medical terminology required
- Familiar with medical procedure and laboratory fees
- Ability to understand a clinical trial financial contract
- Excellent organizational and time management skills required
- Excellent attention to detail skills required
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.
- 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.
Classified Title: Sr. Research Program Coordinator
Starting Salary Range: $38,920 - $53,520 annually (commensurate with experience)
Employee group: Full Time
Schedule: M-F, 8:30AM - 5:00PM
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM Rad Nuclear Medicine
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 at [email protected]
. 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
To apply, visit https://jobs.jhu.edu/job/Baltimore-Sr_-Research-Program-Coordinator-MD-21287/761357300/
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