Department: Instittute for Clinical and Translational Research Work Schedule/Hours: Monday-Friday/8:30-5p/40 hours Location: East Baltimore Personnel Area: School of Medicine
The Johns Hopkins Institute for Clinical and Translational Research (ICTR) is seeking motivated applicants to participate in a two-year comprehensive training and mentoring program for new research study coordinators. The Study Coordinator Apprenticeship and Mentoring Program (SCAMP) will make use of the ICTR’s unique educational programs, clinical infrastructure and expert consultative resources to develop highly-trained, experienced and certified coordinators who are ready to enter the workforce as a clinical research coordinator in academic medicine or pharma.
The two-year SCAMP consists of regular (bi-weekly to monthly) courses and lectures in progressively advanced topics in research coordination; study coordinator work assignments; weekly hour-long, one-on-one mentoring meetings with the program manager, an experienced research coordinator; and a weekly half-day seminar with the entire apprenticeship class to discuss progress and problems encountered during their work week. These seminars will be facilitated by the SCAMP manager and guest senior study coordinators to help guide the discussion and problem solving. Throughout the program, apprentices will attend also regional meetings and classes with the Association for Clinical Research Professionals (ACRP), with the goal of obtaining the Clinical Research Coordinator certification (CCRC) at the end of the program. The SCAMP will fund apprentices’ ACRP membership, exam fees, and each spring the program will fund the second year apprentices’ attendance a national clinical research meeting. Apprentices will participate in work assignments that provide experiences of increasing complexity and responsibility throughout the two years of the program. For example, new apprentices may be assigned to shadow experienced study coordinators, assist clinic staff in the Johns Hopkins Clinical Research Units, or do data entry.
More experienced apprentices might be expected to do routine study coordinator assignments like recruiting and consenting subjects, conducting research interviews, processing biospecimens, or completing case report forms. By the end of the two-year internship, it is expected that apprentices will be comfortable with tasks like protocol development, study budget preparation, preparing and submitting IRB applications, writing consent forms, preparing physician orders, and shadowing or assisting the regulatory personnel in the preparation of FDA paperwork for IND/IDE submissions. Senior apprentices will also be expected to prepare and teach some of the SCAMP classes, and to assist the SCAMP manager in mentoring the first year apprentices.
Specific duties & responsibilities:
• Attend all trainings, lectures and courses as detailed in the SCAMP curriculum.
• Participate in weekly one-on-one mentoring sessions with SCAMP Manager.
• Participate in weekly seminars on study coordination.
• Attend other classes and trainings as assigned by the SCAMP Manager.
• Complete progressive study coordinator work assignments, which can include
• Independently coordinate blood and tissue banking protocols to ensure proper collection and handling of samples, i.e. bone marrow, blood, tissue, skin, check swabs, etc.
• Identify prospective patients for multiple research protocols
• Prepare consent documentation
• Independently conduct consenting process or ensure consent is obtained on appropriate patients
• Ensure proper samples are obtained and distributed and catalog patients for future tracking.
• Maintain familiarity with assigned accruing clinical trials
• Participate in clinical trial start-up meetings
• Evaluates feasibility of protocol-driven blood and tissue sampling
• Identify potential problems and discusses issues with appropriate staff and/or sponsors for prompt resolution.
• Collaborate with internal and external laboratories processing clinical trial samples to ensure compliance with each individual trial.
• Obtain and maintain excellent IV and phlebotomy skills;
• Obtain clinical trial-driven blood samples, processes, stores, labels and ships, as appropriate per each individual clinical trial, ensuring quality samples.
• Independently arrange courier service, as needed for transport of clinical trial blood and tissue samples.
• Obtain and maintain excellent operating knowledge of all assigned clinical equipment and clinical computer systems.
• Assist research nurses, study coordinators, principal investigators and other study personnel in outpatient patient care areas in executing clinical trial-driven activities as directed.
• Assist as needed with in-services for clinical support staff (phlebotomists, clinical associates, medical assistants, etc.) for each new clinical trial regarding applicable clinical details.
• Resolve any schedule conflicts and ensures timely patient tracking.
• Contact clinical trial patients as appropriate with special instructions prior to upcoming tests/exams.
• Intervene, as necessary, on issues relating to patient complaints, and operational issues, and take measures to correct situation or ensures appropriate personnel are involved.
• Ensure adequate supplies are maintained, i.e. shipping, laboratory, office, specimen handling, etc.
• Order clinical-trial specific shipping materials, medical supplies.
• Independently arrange routine and emergent equipment maintenance and repair.
• Represent department on support staff-related administrative issues and assist in the development of support-related policies and procedures.
• Audit to ensure specimen quality assurance is consistently maintained throughout clinical trial.
• Maintain current support documentation on all clinical care provided to increase clinical trial compliance.
• Anticipate daily changes in schedule, maintaining a smooth patient flow.
• Use universal safety precautions to protect self and co-workers from bio-hazardous materials, including blood-borne pathogens.
• Read and understand scientific protocols to prepare study reports and materials
• Write and distribute study correspondence
• Create study materials and assist in their publication
• Attend study meetings, prepare minutes; generate data status, clinic performance reports
• Serve as liaison with clinics re: data quality issues and study procedures
• Maintain disposition of study publications, documents, and IRB approvals
• Review and maintain certification material from clinics, write, revise, and assist in the publication of study documents, e.g. manuals of procedures, consent statements, policy and procedures memoranda
• May conduct data audits and monitor issues such as study drug management at clinical centers
• May participate in site visits.
• Work directly with the principal investigator and other study coordinators to amend, develop, and execute study protocols.
• Schedule and execute all components of both acute and follow-up visits for research subjects.
• Monitor study budgets
•Monitor subjects’ progress throughout involvement in the research protocol.
• Manage and maintain all participant binders, study binders, and documentation for the study.
• Prepare for audits
• Assist the principal investigator in all aspects of the trial, including advertising, implementing new recruitment strategies, preparing reports to the IRB (including Continuing Review Applications, Adverse Event reports, and Protocol Deviation reports), handling and documenting all correspondence with the IRB, and database design and management.
• Mentor less experienced apprentices
• Prepare and lead trainings, classes, lectures within the SCAMP curriculum.
• Other duties as assigned.
High School Diploma/GED, with minimum of 2 years of relevant experience. Additional education may substitute for experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 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.
Bachelor’s Degree in related discipline
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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.
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