Research - Laboratory/Non-Laboratory, Staff/Administrative
The Research Program Manager has the overall responsibility of facilitating development andmonitoring the progress of a large multicenter clinical trial in the Department of Neurosurgery. Oversee the developmentand management of the clinical trialand develop associated strategic relationships with vendors, researchers, and clinicians in accordancewith study objectives and applicable regulations.
Specific duties & responsibilities:
Participate in the analysis, planning and strategic formation of program goals for assignedtrial.
Coordinate and oversee all research activities for a large multi-center clinical trial, assisting with preparing, reviewing, and approving all reporting information needed for IRB, FDA, and industry sponsors
Anticipate or identify project needs and maintain a development plan that is consistent with the latestregulatory requirements, cost-effective and efficient, and provides for safety of participating subjects.
Manage the relationships with development partners and external vendors (i.e.: CROs, consultants). Serves as a central resource for collaborators conducting research.
In coordination with contract research organizations (CRO), oversee implementation of the clinical study to maintain protocol and regulatory compliance for activities such as informed consent, patientsafety, and quality data.
Implement supplier audits to support ongoing compliance.
Develop and implement SOPs for the clinical trial and related activities.
Author and/or review and approve study documents.
Prepare metrics and summaries to effectively communicate status and recommendations to SeniorManagement.
Ensure and/or conduct required training for investigator sites on the clinical trial;including but not limited to Investigator Meetings, policies, procedures, study conduct, data management, and regulatory requirements.
Support Pharmacovigilance activities as required.
Provide recommendations and input regarding departmental policies, procedures, goals andobjectives; make judgments and decisions in a sound logical manner.
Provide direction to other team members.
Attends and participates actively in research management meetings. Assists PI with protocol development which may include writing informed consents.
Initiate and/or maintain activities, systems and processes to increase referrals and increase accruals to multiple clinical trials.
In coordination with the CRO, ensures all proper regulatory documents have been approved and that all documents, CRF, databases, monitoring/auditing requirements have been completed.
Assures protocol and study manuals have complete, consistent language throughout, including proper SAE (serious adverse event) reporting requirements, coordinating center requirements, etc.
Evaluates for recurrent problems. Develops and implements systems to decrease delays.
In coordination with the CRO, prepares and submits FDA reports for IND application
Minimum qualifications (mandatory):
Bachelor degree in related discipline required (e.g. health or life sciences)
Minimum of 5 years of experience in clinical research at an academic, government, or pharmaceutical industry environment.
Additional education may substitute for some experience, to the extent permitted by the JHU equivalency formula. 18 graduate degree credits may substitute for one year of experience. 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.
Thorough knowledge of cGCPs, FDA/ICH and global regulatory requirements
Experience in writing/reviewing clinical trial and regulatory documents
Experience in protocol and informed consent writing, data analysis, and /or manuscript preparation required. Experience in budget generation, contractual process and financial management of clinical trials preferred.
Experience with CROs, Investigative Sites
Strong organizational, interpersonal and communication skills to plan and accomplish goals
Team-oriented approach to project management and problem resolution
Classified Title: Research Program Manager Working Title: Research Program Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $52,495-$72,210 Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 60002728-NUS Pain Institute 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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