Under the direct supervision of the Senior Research Coordinator (supervisor) or the Principal Investigator, the Research Program Coordinator will be responsible for research participant recruitment, performing research participant study visits which include administering questionnaires and collecting participant samples. The RPC will also be responsible for the organization, entry, maintenance and accuracy of study regulatory reporting and all participant research data in a timely and ongoing manner. The RPC will assist the Senior Research Coordinator with tasks related to the initiation and execution of clinical research studies. We are looking for a highly motivated and organized individual who demonstrates the ability to work independently, reason critically and a high level of accountability and attention to detail. Training will be provided onsite for tasks.
Specific Duties & Responsibilities:
Maintain detailed working knowledge of all study protocols, operating procedures, and source documentation.
Follows all written and unwritten study practices, procedures and protocols. Provide detailed weekly updates to supervisors regarding study progress, regulatory items, data collection, study invoicing, and participant payment as well as any obstacles encountered.
Recruit and screen potential study participants according to protocol's inclusion and exclusion criteria; ensure study activities are completed correctly and completely.
Ensure that proper written informed consent from each study participant is obtained prior to entering study; ensure that the original signed and dated consent from each study participant is filed in participants' research record. Scan copies of consent forms and related documents to be uploaded into participant's Epic medical record.
Coordinate study participant visits and follow-up, schedule appointments with study participants, make telephone reminders, send recruitment letters, track and locate participants.
Conduct interviews over the phone or in person to determine eligibility for a research study.
Design and maintain organizational tools to conduct the study accurately and in compliance with Good Clinical Practice.
Maintain participant's follow-up tracking database; maintain records of study participants' status by using an enrollment log.
Maintain an organized filing system for electronic and paper-based research records according to HIPAA and IRB regulations and guidelines
Responsible for IRB submissions (applications, changes in research, adverse event reporting, protocol deviations, amendments and annual renewals), verification and maintenance of necessary protocol specific information in paper and electronic format to meet requirements of IRB and all relevant regulatory bodies. Notify supervisors of all IRB submissions.
Experienced in and responsible for compliance and timely reporting to Hopkins IRB, external/central IRBs, study sponsors, and contracted research organizations as well as supervisors.
Liaison between the research team and Office of Research Administration to facilitate all contracting and budget development.
Ensure accurate and timely data collection for all assigned studies. Input, organize, edit, and verify accuracy of data in databases and source documentation. Create and maintain database for study analysis.
Keep the Clinical Research and Management System (CRMS) up to date with patient eligibility and enrollment in research studies.
Experienced in SAP and responsible for maintaining inventory of study related supplies. Utilize SAP for study related purchases, invoicing, and participant payment.
Prepare weekly study progress reports and participate in weekly team meetings to report on recruitment progress and resolve problems.
Perform routine tests in a research laboratory. This will potentially include patient sample processing, such as blood and sputum processing.
Phlebotomy certification and perform research blood draws.
Shipping and receiving of specimens and transport of specimens if necessary.
Assists in training less experienced personnel in study procedures.
Assist in the writing of post study data results and findings.
Minimum Qualifications (mandatory):
Bachelor's degree in related discipline required.
Some related experience required.
Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Ability to work independently and efficiently.
Excellent oral and written communication skills and interviewing techniques helpful.
Experience with EPIC or similar electronic patient records system extremely beneficial.
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.
Special Knowledge, Skills, and Abilities:
Comfortable handling and transporting biospecimens from patients
Position requires flexibility.
Ability to work independently and manage multiple tasks, detail oriented, self-motivated, strong interpersonal skills.
Ability to use personal computer; proficiency in Microsoft Word and Excel.
Database and spreadsheet knowledge required.
Excellent oral and written communication skills and interviewing techniques required.
Detail oriented, Strong interpersonal skills and excellent organizational and time management skills required.
Technical Qualifications or Specialized Certifications:
Standard HIPAA courses must be completed and appropriate exams passed with necessary certification within 2 weeks of start date.
EPIC training courses (if not already done) to be completed within 1 month of start date.
Any Specific Physical Requirements for the Job:
Sitting in a normal seated position in office setting
Standing and/or walking for extended periods of time
Lifting and/or assisting patients during evaluations within crowded clinical environment
Reaching by extending hand(s) or arm(s) in any direction
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard
Communication skills using the spoken word
Ability to see within normal parameters
Ability to hear within normal range
Ability to move about
Classified Title: Research Program Coordinator Working Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26-$22.35 Employee group: Full Time Schedule: Monday-Friday/40 hours Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 10002817-SOM DOM Pulmonary 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@example.com. 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.
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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.