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Sr. Research Program Coordinator

Employer
Johns Hopkins University
Location
Maryland, United States
Salary
Salary Not Specified
Date posted
Mar 3, 2022

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This Research Program involves research with human subjects with mild memory impairments and sleep complaints, who will be evaluated with sleep measures (actigraphy and home sleep tests/polysomnography), clinical assessments, cognitive testing, brain imaging, and blood assays.

We are seeking a Senior Research Program Coordinator (Sr. RPC) who will be responsible for implementing the day-to-day operations of the NIA-funded clinical trial titled “RCT Targeting Cognition in Early Alzheimer’s Disease by Improving Sleep with Trazodone (REST).” The Sr. RPC will work with a team of investigators in the Johns Hopkins School of Medicine and School of Public Health, including Drs. Barry Greenberg and Paul Rosenberg (co-Principal Investigators), Drs. Cynthia Munro and Greg Pontone, (Clinical and Cognition Team), Drs. Arnold Bakker and Abhay Moghekar (Imaging and Fluid Biomarkers Team), and Drs. Adam Spira and Mark Wu (co-leads, Actigraphy-Sleep Team).

As such the Sr. RPC will oversee and coordinate the work of other support staff working on the project. The ultimate goal will be to recruit and follow 100 study participants (20/year x 5 years) who have mild cognitive impairment and sleep complaints. Participants will be enrolled into a clinical trial protocol lasting approximately 13-15 weeks, as a blinded randomized cross-over design of the study drug or placebo for 4 week duration, a 4-week no-drug washout, and then a 4-week treatment phase on the opposite treatment, with intermittently scheduled clinical and cognitive assessments, brain imaging, home sleep tests and blood sampling.

Participants are initially evaluated with a clinical and neuropsychological assessment, a home sleep test, and a brain magnetic resonance imaging (MRI) scan prior to drug randomization. They will be evaluated in-person at the Johns Hopkins Bayview Medical Center at enrollment and at follow-up, with brain imaging performed at the Kennedy Krieger Institute. The Sr. RPC will be responsible for assuring that these evaluations follow the Standard Operating Procedures established by the REST executive team and coordinating center, and facilitate the participation of the study subjects through their various procedures.

Specific Duties & Responsibilities:

  • Maintain good working knowledge of all study protocols, including inclusion and exclusion criteria for study participation, visit timelines, and required data collection points per protocol.
  • Working closely with Drs. Greenberg, Rosenberg and Bakker, and a research nurse manager, recruit and evaluate study participants, coordinating these efforts with those of the clinical trials research group at Johns Hopkins Bayview campus, participating in overall outreach, advertising, and recruitment across research studies.
  • Direct the participation of Bayview clinical trial research group colleagues involved in REST study recruitment and retention.
  • Administer phone screens and verify participant eligibility for study components by comparing subject’s history and clinical laboratory results with protocol requirements.
  • Maintain recruitment databases and spreadsheets for tracking participant visits and recruitment efforts.
  • Coordinate and schedule participant screening and follow up visits as specified per protocol. Respond in a timely manner to queries related to each protocol. Administer cognitive testing and questionnaires for research subjects according to protocol specifications. Accompany subjects if needed to facilitate their participation in study protocols that may require physical presence at more than one clinical location.
  • Maintain research charts for each study participant. Ensure accuracy and timeliness of data entry into protocol specific databases, and respond to and correct data queries raised by study team leadership.
  • Prepare and submit annual renewal requests, protocol amendments, and adverse event reports to institutional entities and sponsors.
  • Adhere to all protocol requirements to ensure the validity of the clinical research data. Maintain regulatory binders for each assigned protocol.
  • Meet regularly with study team leadership to review data accuracy and overall study progress. Participate in all mandatory meetings to develop increasing knowledge of assigned clinical trial requirements.
  • Prepare for and participate in monitoring and audits of the study. Correct errors in database when necessary.
  • Maintain good communication with study sponsor, regulatory contacts, and clinical monitors.

These responsibilities may involve travel between several Johns Hopkins medical campuses including the Bayview Medical Center and the main East Baltimore medical center. A flexible daily time schedule will sometimes be necessary, based on the study participant visit needs and the available staffing.

Minimum Qualifications (Mandatory):

  • Bachelor's Degree in related discipline required
  • Minimum of 3 years of related experience in a health-related field.
  • 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.

Preferred Qualifications:

  • At least 1-year experience as lead coordinator of a clinical research study preferred.

Special Knowledge, Skills & Abilities:

  • Ability to learn new database and software applications.
  • Excellent organizational skills.
  • Excellent attention to detail skills.
  • Ability to follow multiple, detailed directions of various protocols.
  • Must have excellent time management skills.
  • Must have excellent oral and written communication skills.
  • Ability and licensure to operate a motor vehicle.
  • Ability to maintain confidentiality.
  • Must be able to work independently with modest direction.
  • Good interpersonal skills.
  • Good organizational skills.
  • Requires familiarity with basic medical terminology, excellent organizational skills, good computer skills (including use of EXCEL and REDCap), the ability to handle detailed quantitative information and the ability to be accurate when coding data, reviewing forms for completeness and handling data entry.
  • Proficiency in PC operations and software application such as MS Windows, Excel, Word, and Access.

Physical Requirements:

  • Ability to stand, walk or sit for an extended period of time.
  • Ability to climb stairs.
  • 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.
  • Possible exposure to communicable diseases.

Supervisory Responsibility:

  • Dr. Rosenberg currently supervises a staff of 3 RPCs and two managers functioning as a memory clinical trials unit at Bayview.
  • These RPCs will serve as backup staff for the Sr. RPC, and thus the Sr. RPC will need to supervise them as needed to fulfill these duties.

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 8:30 am - 5:00 pm
Exempt Status: Exempt
Location: ​​​​​​​Johns Hopkins Bayview
Department name: ​​​​​​​SOM Neuro Cognitive Neurology
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 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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf


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 jhurecruitment@jhu.edu. 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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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