The Department of Oncology is seeking a Clinical Research Regulatory Specialist II that will be responsible for all aspects of study start up. This role will serve as a central resource for faculty conducting clinical research. Working closely with the Program Manager, Research Nurse, pathology, lab managers, and sponsors this position will complete and submit the initial IRB submission and budget for a variety of protocols. Prior to the start of a study, will ensure all proper regulatory documents have been approved and that all documents, CRFs, databases, monitoring/auditing requirements have been completed. Will produce and maintain a regulatory binder prior to the study initiation with all required documents and additional sections for future documents. Works closely with the study coordinators to ensure all documents are submitted to the IRB in a timely manner and invoice for study procedures.
Specific Duties & Responsibilities:
Work closely with the Research Nurse and PI on new studies to ensure timely, accurate submission to the IRB and sponsors
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
Prepare reports and present updates on protocol submission process
Complete new study IRB submissions
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
Prepare and submit study budget to sponsor and internal research administration department
Prepare, submit and track invoices for study procedures during the course of study
Work with Financial Manager to ensure all billing is accurate on a quarterly basis and prior to study closeout
For IND studies, maintain accurate and up-to-date documents and submissions
Collect all required documents from sites where SKCCC is the coordinating center prior to study opening
Coordinate and attend study start up meeting for studies where SKCCC is the coordinating center
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 to a study opening
Work with internal and external vendors to resolve regulatory related issues prior to initiation and act as a resource for ongoing regulatory maintenance.
Work closely with the study coordinator(s)to ensure all documents are being collected in a timely manner and all regulatory binders are up-to-date, helping as needed
Develop standard operating procedures as needed
Assist CRO in the auditing and monitoring of studies, including external
Minimum Qualifications (mandatory):
Bachelor’s degree in health sciences, biological sciences, or related field required.
3 years of experience in academic or industry-based clinical research required.
Must have familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research.
Excellent verbal and communication skills are required.
Additional graduate education may substitute for required experience to the extent permitted by the JHU equivalency formula.
Master's degree in regulatory, health sciences, biological sciences, or related field preferred.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.
Technical Qualifications or Specialized Certifications:
SOCRA, Certified IRB Professional or other clinical research certifications.
Classified Title: Regulatory Specialist II Working Title: Regulatory Specialist II Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920-$53,520 Employee group: Full Time Schedule: Monday-Friday/8:30am-5:00pm/37.5 hours Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002942-SOM Onc Breast and Ovarian Cancer Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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.
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