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 **This position is not eligible to provide H-1B Visa Sponsorship.**

General summary/purpose:

The Sr. Research Program Coordinator is responsible for coordinating clinical research activities within the Johns Hopkins Sjogren's Syndrome Center.  The individual's responsibilities will include coordination of the NIH-funded STAMP (Sjogren's Team-Accelerating Medicines Partnership) research project (75% effort) at Johns Hopkins and other clinical research activities within the Sjogren's Center (25% effort). Requisite tasks will include patient recruitment and scheduling, data collection and management, specimen handling, compliance with IRB regulations, and administration of the STAMP research project. The individual will act as a liaison between the principal investigator, School of Medicine, Research Administration, GCRC, funding agencies and other study related organizations.

Specific duties & responsibilities:

Clinical Research Activities

1. Assist the principal investigator with STAMP and other clinical research projects.
2. Identify potential study participants and assist in their recruitment into STAMP and other research studies.
3. Assist clinicians with patient screening and verification of eligibility for specific research studies.
4. Obtain informed consent from potential study participants after providing a detailed description of the study, the study procedures, and potential risks, and answering all questions.
5. Schedule patients' appointments and follow-up visits/phone calls at the appropriate time to assure completion of protocol requirements. This may require coordination of multiple appointments and centers.
6. Perform structured tests in the clinic and complete various assessment tools and questionnaires related to each study.
7. Collect patient source documents and case report forms for analyzing patient data.  
8. Be responsible for the organization, entry, maintenance and accuracy of patient clinical research data.
9. Coordinate same-day blood shipments for cohort studies to central lab for processing.
10. Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus
11. Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
12. Maintain detailed working knowledge of all assigned protocols. Adhere to all protocol requirements to ensure the validity of clinical research subject data.
13. Work with pharmaceutical companies in study design and/or determine what group can commit to, based on patient population, available resources, and cost of providing services.

Regulatory Compliance

1. Comply fully with institutional and external clinical research requisites.
2. 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.
3. Design and compile materials which aid physicians and other staff in complying with protocol requirements
4. Maintain regulatory binders per protocols
5. Document and report adverse events and protocol deviations.
6. Organize and create clinical research charts to be reviewed by regulatory agencies.
7. Complete training requirements for biohazard material handling and department of transportation (DOT) shipping requirements.
8. Be familiar with good clinical practice guidelines and knowledge of sponsor and FDA guidelines.

Data Management

1. Develop standard operating procedures and data collection forms from protocol(s).
2. Maintain and promptly update online Clinical Research Management System for each study protocol
3. Assist with preparation of data for reports and presentations
4. Respond in a timely manner to special projects or queries related to data.
5. Design and implement procedural adjustments to increase accuracy and efficiency of data collection and entry process
6. Organize and quality controls raw data; use standard statistical techniques and/or package programs to run standard statistics.
7. Perform quality checks on data entry
8. Ensure accuracy and timeliness of data collection. Interact regularly and facilitate the completion of work with members of the research team regarding data management and the status and progress of ongoing studies.
9. Abstract patient clinical and demographic from a variety of sources and enter into tracking spreadsheet or data base
10. Develop consent form(s) for clinical trials from protocol(s). Prepare materials for IRB
11. Organize and quality controls raw data; use standard statistical techniques and/or package programs to run standard statistics.

Scholarly Activities

1. Assist with writing manuscripts and abstracts for publication
2. Assist with development of grants, progress reports and study protocols
3. Conduct literature searches to provide background information. Abstract and index information based on knowledge of subject matter.

Research Program Oversight

1. Meet regularly with Principal Investigators to review data accuracy and overall study progress.
2. Work with Center manager and study sponsor (where appropriate) on problem recognition/resolution, accuracy of data gathered and patient well-being, completion and collection of regulatory documents required by sponsors.
3. Prepare for and participate in audits of studies including follow-up items
4. Perform self-audits and audits other sites.
5. Recommend changes to protocol operations based on results and goals.

Financial Management

1. Keep records of expenditures and work with budget analysts to ensure accurate and prompt reporting of study financials
2. Maintain compensation records for participants.
3. Participate in developing study budget.

General

1. Oversee day-to-day activities of support staff on study. Train new staff at single and/or multi-clinic sites.
2. Carry out duties and responsibilities with limited supervision
3. Travel to and participate in investigator and research coordinator meetings. 
4. Maintain equipment and order research supplies related to clinical research protocols.
5. Report progress to Center Director and ensure satisfactory completion of research projects.

Minimum Qualifications (mandatory):

• Bachelor's degree in a related field is required.
• Three (3) years of related research program coordinator or other related experience required.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

JHU Equivalency Formula: 18 graduate degree credits (semester hours) 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.

Preferred Qualifications:

• Master's degree preferred.     

Special knowledge, skills, and abilities:

• Highly effective verbal communication and interpersonal skills

Classified Title: Sr. Research Program Coordinator
Role/Level/Range: ACRP/03/MB 
Starting Salary Range: $39,310 - $54,060 annually (commensurate with experience)
Employee group: Full Time 
Schedule: M-F 8:30am - 5:00pm 
Exempt Status: Exempt 
Location: Johns Hopkins Bayview 
Department name: SOM DOM Bay Rheumatology 
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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

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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