We are seeking a Senior Research Program Coordinator whois responsible for coordinating clinical research activities for the Johns Hopkins Myositis Center. They will oversee all facets of research activities, including patient recruitment and scheduling, data collection and management, specimen collection, handling and processing, compliance with IRB regulations and communicating with team members on the status of projects. The Sr. Research Program Coordinator will act as primary liaison between principal investigator, School of Medicine, Research Administration, Clinical Research Units, funding agencies and other study related organizations.
Specific Duties & Responsibilities:
Clinical Research Activities
Assist principal investigators with multiple clinical research projects. Work on clinical studies requiring a high level of knowledge, coordination and data abstraction
Assist clinicians with patient screening, consenting and verification of patient eligibility for studies
Conduct research testing with patients, including but not limited to muscular strength and sensory testing, ataxia evaluations
Conduct intervention trials and international studies in compliance with International Council of Harmonization (ICH) regulations
Explain protocol procedures to patients and obtain informed consent
Schedule patients' appointments and follow up visits/phone calls at the appropriate time to assure completion of protocol requirements, which may require coordination of multiple appointments and centers
Be responsible for organization and completeness of clinical research data, including data entry, maintenance of records and accuracy of the data
Design and compile materials and standard operating procedures which aid physicians and other staff in complying with protocol requirements
Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies
Collection, processing and shipping of biospecimen as requested by research protocols according to DOT/IATA regulations
Collect patient source documents and case report forms for analyzing patient data
Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus
Perform structured tests within the myositis clinic, including various assessment tools and questionnaires
Coordinate the collection and documentation of patient information for research purposes
Organize and create clinical research charts to be reviewed by regulatory agencies
Maintain a research database of patients enrolled in clinical trials
Participate in and or organize community events to increase public awareness
Responsible for Institutional Review Board (IRB) submission, verification and maintenance of protocol specific information. Prepare and submit annual renewal requests, amendments and safety reports according to IRB requirements
Maintain regulatory binders per protocols
Document adverse events and protocol deviations
Complete and maintain required certifications / training, e.g. CITI or DOT/IATA certification
Responsible for maintaining and promptly updating online Clinical Research Management System
Assist with preparation of data for reports and presentations
Design and implement procedural adjustments to increase accuracy and efficiency of data collection and entry process
Perform quality checks on data entry
Ensure accuracy and timeliness of data collection. Interact regularly and helps facilitate the completion of work with members of the research team regarding data management and the status and progress of ongoing studies
Assist with writing manuscripts and abstracts for publication
Assist with development of grants, progress reports and study protocols
Research Program Oversight
Meet regularly with Principal Investigators to review and discuss research data and overall study progress
Work with the Center Directors and/or study sponsors on problem recognition/resolution, data accuracy and regulatory documentations as required by study sponsors
Prepare for and participates in monitoring visits and audits
Conduct periodic audits under the direction of the Program Coordinator and/or PI
Keep records of expenditures and work with budget analysts to ensure accurate and prompt reporting of study financials
Create clinical research budgets, oversee account activities, prepare invoices
Minimum Qualifications (Mandatory):
Bachelor's Degree in related discipline
3 years related experience in clinical research
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula
*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.*
* Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Experience in phlebotomy preferred
Special Knowledge, Skills & Abilities:
Microsoft Word, Excel
Classified Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: Commensurate with experience Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: Johns Hopkins Bayview Department name: SOM Neuro Neuromuscular Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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 Talent Acquisition Office at email@example.com. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.
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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