CAPRES was created to facilitate and highlight the research element of the JHM tripartite mission in the JHM hospitals in the National Capital Corridor — Suburban Hospital, Sibley Memorial Hospital, and Howard County General Hospital. CAPRES mission is to create an environment for research activities within the 3 hospitals by providing local infrastructure, access to JHM resources, expert staff, and research subjects.
We are seeking a Sr. Research Program Coordinator who will work with multiple Principal Investigators to perform the responsibilities inherent in clinical research studies. The Senior Research Program Coordinator is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the coordinator supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Specific Duties & Responsibilities
Plans and coordinates the initiation of research study protocol, and the establishment of operating policies and procedures.
Plans, implements, and maintains data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data.
Recruits, instructs, and coordinates research subjects and/or volunteers, as appropriate to specific study objectives and work scope.
Coordinates the day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
Plans and coordinates the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity.
Supervises and coordinates the provision of support services to investigators and researchers.
Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
Maintain a database to track progress of CAPRES open protocols, accruals, and research proposals as well as any required CAPRES site database.
Utilizes knowledge about policies and procedures at both institutions to assist researchers gain approval of protocols and move their protocols efficiently and quickly to completion.
Support research teams in developing timelines of assigned tasks and facilitate better coordination among the administrative offices.
Work closely with Office of Research Administration, Office of Human Subjects Protection, Office of Research Billing and the Technology Transfer Office at JHU and equivalent offices at the CAPRES site as appropriate.
Utilizes comprehensive knowledge about Federal regulations (e.g.: FDA, OHRP, NIH) to guide investigators through the process.
Maintains awareness of all of the offices/programs within CAPRES and JHM research administration including IRB that are available to assist research teams at both institutions.
Liaison between PI's, co-investigators, research nurses, study coordinators and research offices at JHM and CAPRES site, and common sponsors such as the NIH and industry. Utilize a thorough knowledge of policies and procedures for approval and implementation of protocols to ensure work moves as quickly as possible through the system and to study completion.
Assist and collaborate on complex clinical studies which require a high level of knowledge, coordination, and data extraction.
Assist with preparing and maintaining all IRB and other regulatory documentation as required for multiple studies.
Assist with IND submissions and tracking of IND records as required. It could also include work with outside auditors, corporate sponsors, or federal regulatory agencies like OHRP, the FDA, or NIH.
Assists with preparation of clinical budgets for all projects.
Operates with a high degree of independence in performance of functions.
Participates in budget/contract review and negotiations as required.
Implements quality control process throughout the conduct of the trial.
Participates in clinical floor activities on an ongoing basis with research staff to ensure adequate clinical support for trial activities.
To perform miscellaneous job-related duties as assigned.
Bachelor's Degree in related discipline.
Three years related experience in clinical trials/medical research comparable to overseeing the administrative and scientific implementation of research protocol(s) for complex and/or multiple research studies.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
A Master's Degree is preferred.
Certification as a Clinical Research Professional desired.
Special Knowledge, Skills & Abilities
Understanding of ICH/GCP guidelines for human research.
Understanding of Code of Federal Regulations for Human Subject.
Computer Competency including proficiency in Microsoft Word and Excel.
Understanding Phases I-IV drug development processes.
Ability to manage multiple and competing priorities.
Ability to work independently as well as with various research teams.
Effective interpersonal skills: must be a self-starter who can comfortably work with physicians and staff.
Excellent time management skills.
Excellent attention to detail.
Excellent oral and written communication skills.
Proficiency in the use of software applications, databases, spreadsheets, and word processing required.
Knowledge of personal computer and good working knowledge of laboratory equipment. Must be reasonably proficient at troubleshooting equipment.
Experience in clinical research at an academic, government, or pharmaceutical industry environment preferred.
While performing the duties of this job, the employee is frequently required to stand, walk, climb, reach, sit, bend, push/pull, kneel, stoop, crouch, life, balance and perform repetitive movements.
The employee must lift up to 50 pounds independently and up to 300 pounds through assisted lifting.
The employee uses hearing, speech, smell and tactile senses.
Specific vision abilities include close vision, distance vision, color vision and the ability to adjust focus.
Requires standing and/or walking for long periods.
The noise level is usually moderate.
Work pace is generally steady with occasional hectic periods due to patient census, status, or emergencies.
Subject to shift rotation.
Subject to exposure to blood-borne pathogens, latex, dust, fumes, odors, mists, gasses, biological, mechanical, electrical, chemical and other hazardous materials. Incumbent may be exposed to moving machinery.
The incumbent is expected to adhere to the Hospital's Drug and Smoke Free work environment and to adhere to OSHA mandates and precautionary measures.
Classified Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: Min $40,900 - Max $71,600 Annually ($70,000 targeted; Commensurate with experience) Employee group: Full Time Schedule: M-F 37.5 8 am - 4 pm Exempt Status: Exempt Location: JH at Bethesda Department name: SOM Admin Res Clinical Research Contract Personnel area: School of Medicine
Total Rewards The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. 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.
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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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