Classified Title: Sr. Research Program Coordinator Working Title: Sr. RPC Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,537-$52,989 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: 10003520-SOM Neuro BIOS Personnel area: School of Medicine
The Sr. Research Program Coordinator (SRPC) will oversee the day-to-day activities of multiple complex studies coordinated by the Division of Brain Injury Outcomes. The SRPC will also assist in study design and contribute to standard operating procedure development.
Specific duties & responsibilities:
The SRPC will have the critically-important responsibility for establishing early lines of communication with the clinical teams as they are selected and prepared for activation. S/He will be integral to propel the subject accrual and monthly goals of enrollments per month across all sites. The SRPC will prepare site evaluations detailing the availability of critical local resources necessary to be successful at enrollment and protocol performance once the trial begins. S/He will assist each clinical team to prepare materials through the central IRB process.
During trial implementation, the SRPC will oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion. S/He will conduct monthly (or more frequent) teleconferences with the clinical teams and individually mentor new coordinators. The SRPC is critical to keeping enrollments on track with established performance expectations. S/He will have monthly goals set for prestart activities aligned with an established 90-day start-up plan, site activation, enrollment numbers, site contacts, and clinical team data entry completion. The SRPC will also provide support for quality assurance monitors and Research Program Managers in all facets of work related to communications with and management of the enrolling center clinical teams. S/He will assist sites in central IRB on-boarding, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
The SRPC is responsible for training materials and training resources (educational modules, websites, investigator meeting presentations, monthly meetings, newsletters, etc.). S/He will work with the enrolling center investigators to continue to identify and correct problems of compliance, data collection, processing, and recruitment and retention by issuing guidance reports, presenting topics at monthly teleconferences, and publishing monthly newsletters.
The SRPC will develop standard operating procedures and may assist with vetting draft data collection forms from protocols. S/He will oversee the day-to-day activities of support staff on study and train new staff within the Division and at multicenter sites. The SRPC will develop consent forms for clinical trials and prepare materials for IRB submission. S/He will participate in developing study budgets and conduct literature searches to provide background information with abstraction and indexing based on knowledge of subject matter. The SRPC will perform self-audits and audit performance of enrolling sites. S/He will recommend changes to protocol operations based on results and goals.
Minimum qualifications (mandatory):
Bachelor degree required.
Minimum of three (3) years' experience in delivering effective project management solutions.
Excellent leadership skills with ability to negotiate and work collaboratively; service-oriented with excellent verbal and written communication and organization skills; knowledge of formal project management methodologies; experience in a higher education environment.
The successful candidate will be expected to operate independently, with guidance provided by Research Program Managers and BIOS leadership. The candidate will have background and experience in clinical research, research protection, federal and regulatory issues, research ethics, pharmacovigilance, regulatory compliance, and project management at the task level.
This position requires a high degree of independent action and adherence to strict timelines. Building and maintaining strong, trusting relationships is critical. The successful candidate will have experience presenting to investigative teams, end-users (faculty and staff), and subject-matter experts and must possess excellent negotiation, facilitation, consensus-building, and diplomacy skills and exhibit a strong helpline orientation. The successful candidate will be expected to stay current with a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel. This individual will serve as a knowledgeable liaison between the BIOS leadership and the enrolling center personnel.
Ability to make independent judgments and to act on decisions on a daily basis. Ability to work for long periods of time without direction. Ability to prioritize own work and work of others as needed. Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines. Very strong organizational skills, analytical and problem solving abilities, and attention to detail. Demonstrated ability to coordinate projects independently and work constructively as part of a team. Will oversee and coordinate the work of teams in other institutions. Ability to maintain confidentiality. Strong interpersonal and communication skills, both oral and written.
This position reports to the BIOS Faculty and leadership.
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.
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