| GENERAL SUMMARY Under the supervision of the Sr. Clinical Research Program Manager and the Director of Thoracic Oncology Program, the Clinical Research Program Specialist is responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. Will serve as a central resource for faculty conducting clinical research. Working closely with the Program Manager and Research Nurse, this position will complete and submit the initial IRB submission. Prior to the start of a study, will ensure that all proper regulatory documents have been approved and that all documents, CRF, databases, monitoring/auditing requirements have been completed. Will produce and maintain a regulatory binder prior to the study starting with all required documents and additional sections for future documents. During the study, the Clinical Research Program Specialist will ensure all documents are submitted to the IRB in a timely manner. Assist with orientation of less senior research staff on regulatory submission requirements. DUTIES AND RESPONSIBILITIES - Work closely with the Research Nurse and PI on new studies to ensure timely, accurate submission to the IRB, sponsors and FDA/CTEP.
- Assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
- Obtain all required documents for new submissions to the IRB.
- Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
- Supervise research coordinators and future regulatory staff on regulatory duties to ensure protocol and regulatory compliance.
- Supervise and guide future regulatory specialists regarding informed consent development and protocol amendments for investigator-initiated studies.
- Contribute feedback to the Sr Clinical Research Program Manager on the progress of research staff while performing regulatory duties.
- Complete new study IRB submissions.
- Complete IRB amendment submissions and ensure documentation of training.
- Ensures smooth implementation of new trials from conception through study activation.
- Work closely with the protocol compliance team to ensure all documents are ready prior to a
- study opening.
- For IND studies, work with the IND specialist to maintain accurate and up-to-date documents and submissions.
- Attend study start up meeting for studies including those where SKCCC is the coordinating center.
- Participate in site initiation visits for studies where Hopkins is the Coordinating Center and Cancer Center investigator is the Lead or Protocol Chair.
- Produce and maintain a regulatory binder prior to study starting with all required documents.
- Work closely with all sponsors to ensure all documents are reviewed, approved and correct prior and during the study.
- Ensure all documents are being collected in a timely manner and all regulatory binders are up to-date.
- Develop standard operating procedures for regulatory submissions as needed.
- Submission of PRL for order development at the time of amendment submission.
- Oversite while study coordinators are working on IRB regulatory submissions including
- Continuing Renewals and SAE submissions.
- 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.
- Review and analyze new studies for difficulties that may arise with study processes and procedures. Suggest appropriate alternatives to possible complications.
- Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies. Teaches staff about regulatory aspects.
- Updates faculty on regulatory study status.
- Maintain clinicaltrials.gov compliance.
Supervision of Others: Equipment, Machine, or Tool Requirements: - General computer skills, with Microsoft Office experience
Education: - Required BA/BS degree in Biological/Social Sciences or other appropriate discipline required.
- Advanced degree may substitute for some experience.
- Certification as a Clinical Research Professional is preferred.
Experience: - Minimum of 5 years of experience in complex and detailed clinical trials/medical research in a patient setting is required. Minimum of two years clinical experience in clinical trial and or clinical research in a patient setting required.
- Knowledge of research methodology and working knowledge of computers required.
- Knowledge of clinical research practices and principles required.
- Highly effective verbal and written communication skills, and highly developed interpersonal skills required.
- Must be able to independently assimilate and evaluate clinical data.
- Proficiency in Microsoft Office, especially Excel and Word, and a working knowledge of Access or other relational database is required.
- Must be familiar with medical terminology.
- Must have working knowledge of FDA reporting requirements.
Special Knowledge, Skills, or Abilities/Competencies: - Excellent organizational skills required
- Excellent attention to detail required
- Must have excellent prioritize skills
- Must have familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research
- Must be experienced in handling multiple tasks at once, and working well as a member of a team.
- Ability to handle multiple and competing priorities
- Ability to interact appropriately and productively with staff at all levels
- Must have excellent time management skills
Classified Title: Clinical Research Program Specialist
Working Title: Clinical Research Program Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $45,195 to $62,225 per year
Employee group: Full Time
Schedule: M-F 8:30
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10002938-SOM Onc Upper Aerodigestive Cancer
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 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
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