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.
Three (3) years’ experience in delivering effective project management solutions.
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.
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.
Classified Title: Sr. Research Program Coordinator Working Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920-$53,520 (commensurate with experience) 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 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.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.