*This Position is not eligible to provide visa sponsorship*

The Johns Hopkins Healthful Eating, Activity & Weight Program is seeking a Senior Research Program Coordinator who will work in collaboration with the Principal Investigator, Dr. Kimberly Gudzune, and will be responsible for the management and oversight of a multi-center clinical trial for obesity. This position will be will be involved in scientific discussions and coordinate the day-to-day logistical and operational tasks, have oversight of clinical research protocols, implement effective participant recruitment strategies, recruitment, screening, scheduling, testing and data management. This individual will enroll patients, and manage the organization, entry, and maintenance and accuracy of all clinical research data for a complex and detailed clinical study. Prior clinical trial experience, particularly with managing multisite clinical trials that include clinical care and pharmaceuticals, is preferred.

• The coordinator will be responsible for day-to-day implementation of the project and will work closely with Dr. Gudzune (site PI) and the team of co-investigators on all aspects of the study, particularly with IRB protocols and study policies, updating protocols and procedures, screening/recruitment, conducting randomization visits, and carrying out the data collection.
• The coordinator will serve to manage the project and team. The coordinator will assist with organizing, planning study meetings and tracking major action items for site activities as well as the Clinical Outcomes, Safety and Intervention Committee. The coordinator will assist with reports to study committees (e.g. data quality reports), the Data Safety and Monitoring Board, the IRB, Clinical Coordinating Center, and NIH-NHLBI (i.e., NIH and IRB progress reports).
• The coordinator will work closely with faculty and staff at the 5 research sites and be present at the trial steering committee meetings.
• The coordinator will also be responsible for day-to-day study activities, especially promotion, screening/recruitment, enrollment, and data collection.
• The coordinator will implement all retention strategies to ensure high rates of follow up and completion of data collection.

About the Research Study:

• The Long-term Effectiveness of the Anti-obesity Medication Phentermine (LEAP) Trial is an NIH-NHLBI-funded randomized controlled trial to determine the efficacy and safety of the anti-obesity medication, Phentermine, to placebo. This is a multisite trial, which includes sites at Wake Forest (North Carolina), Johns Hopkins (Maryland), Health Partners (Minnesota), University of Texas (Texas), and Kaiser Permanente (California). At Johns Hopkins, the intervention will be integrated into care at the Johns Hopkins Healthful Eating, Activity & Weight Program.
• The LEAP intervention includes the following:
  • Randomization to placebo or phentermine
  • Behavioral weight loss program through WW online (or app)
  • Self-monitoring through WiFi-enabled scale
  • Obesity medicine care
• Data collection is from electronic surveys as well as some in-person collection.
• The main outcome is percent weight loss change and change in systolic blood pressure from baseline to 24 months. Other outcomes are change in resting metabolic rate, change in ECG, and drug dependence score.

Specific Duties & Responsibilities:

The Project Coordinator is responsible for helping to develop, coordinate, implement and manage all aspects of the trial:

Overall Trial Site Management

• Organizes, coordinates and runs the weekly research team meetings along with the site PI (Dr. Gudzune). Maintains an organization system to track and manage study-related day-to-day and week-to-week action items.
• Set goals and timelines in collaboration with investigators, and ensure timely accomplishment of project tasks and goals with high quality.
• Works closely with the IRB at the Clinical Coordinating Center (CCC) at Wake Forest School of Medicine to implement and manage the trial protocol locally with the Johns Hopkins IRB, including reliance agreements, changes in research, continuing reviews, and protocol events.
• Confirms patient registrations and relevant data points in databases for the Clinical Research Office and other relevant Information Systems.
• Maintains and updates manuals of procedures for recruitment, retention, procedures for intervention, data collection and data analysis. Assists with reports including recruitment, retention, and data quality.
• Adheres to all protocol requirements to ensure the validity of the complex clinical research data. Manages day-to-day data collection activities, including conducting data collection. Completes accurate, concise, and legible documentation of all participant records and other source documentation and forms per protocol.
• Collects (performs phlebotomy) and handles blood samples. Follows protocol requirements including obtaining specimens by phlebotomy as well as specimen storage and shipment for central processing.
• Performs electrocardiogram (ECG) and resting metabolic rate (RMR) testing. Follows protocol requirements including obtaining test results, site physician review and data transmission to the CCC.
• Manages intervention activities including scheduling of study visits, enrollment in the online behavioral weight management platform (WW online), and distribution of study medication (either placebo or phentermine) in conjunction with site study physicians (Drs. Gudzune, Laudenslager, and Schwartz).
• Recognizes safety concerns among participants and assists with management and coordination with the site PI and co-investigators.
• Works as the liaison at staff meetings for the Healthful Eating, Activity & Weight Program and coordinates intervention logistics in close collaboration with clinic staff, including intervention timing, space and staff needs, as well as data collection.

Clinical Outcomes, Safety & Intervention (COSI) Committee Activities

• Drs. Gudzune and Clark co-chair the COSI committee for the entire LEAP trial, and the coordinator will be integral in this committee as well.
  • Assists with organizing, coordinating and running the monthly meetings of the COSI committee. Maintains an organization system to track and manage study-related day-to-day and week-to-week action items.
  • Coordinates communication, meetings, and action items for the COSI committee to the CCC and all sites.
  • Maintains and updates manuals of procedures for data collection, procedures for intervention, and safety monitoring to be shared across all 5 sites, as well as maintain local manuals for the Johns Hopkins site.
  • Develops and implements quality control procedures for data collection across all 5 sites, as well as maintain local manuals for the Johns Hopkins site.
  • Assists with management of safety reporting to NIH, IRB and the Data Safety and Monitoring Board (DSMB).

Other Trial Committee Activities

• The LEAP trial also includes three other committees: Steering, Recruitment & Retention (R&R), and Publications & Presentations (P&P).
  • Attends the monthly steering committee meetings along with the study PI.
  • Attends trainings at the CCC along with the study PI (may be virtual or require travel to North Carolina).
  • Attends regular meetings of the R&R committee along with Drs. Laudenslager and Schwartz (co-investigators) to represent the Johns Hopkins site. Assists in presenting updates on recruitment and retention to the committee. Provides update on these committees' activities at the Johns Hopkins site meetings. Implements quality control procedures for recruitment at Johns Hopkins as recommended by R&R committee. Implements retention strategies for study participants, particularly the placebo group, at Johns Hopkins as recommended by R&R committee.
  • Attends regular meetings of the P&P committee along with Drs. Laudenslager and Schwartz (co-investigators) to represent the Johns Hopkins site. Provides update on these committees' activities at the Johns Hopkins site meetings.

Other

• Provides other duties as assigned.

Decision Making:

• Makes decisions and establishes work priorities.
• Candidate is responsible for carrying out duties and responsibilities under the supervision of the site PI.

Minimum Qualifications (Mandatory):

• Bachelor's Degree in related discipline required.
• Requires a minimum of three (3) years of related experience.
• Additional education may substitute for some 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. 

** 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:

• MPH or MS in relevant field preferred.
• Previous research study experience strongly preferred, particularly either multisite trial or pharmaceutical trial.
• Knowledge of clinical research practices and principles with an interest in obesity.
• Has understanding of clinical care and workflows.

Special Knowledge, Skills & Abilities:

• Must adhere to guidelines regarding honest reporting of sensitive and confidential research and participant information.
• Understands the importance/impact of data integrity in terms of participants, study results, costs, quality of service and scientific research in general.
• Excellent organizational and time management skills required.
• Ability to work on multiple and competing priorities.
• Excellent interpersonal skills.
• Ability to work well as a member of a team.
• Must work well independently, able to set goals and meet required deadlines.
• Excellent organization skills.
• Independent decision making/trouble shooting abilities.
• Excellent oral and written communication skills in English required.
• Excellent attention to detail.
• Proficiency in the use of Microsoft Office, Outlook, and Excel is required.
• Proficiency in the use of standard software applications and databases, including RedCap, is preferred.
• Phlebotomy training, demonstrated proficiency or willingness to be trained.
• Must be comfortable collecting blood samples from patients.
• Electrocardiogram (ECG) training, demonstrated proficiency or willingness to be trained.
• Resting metabolic rate (RMR) training, demonstrated proficiency or willingness to be trained.

Technical Qualifications or Specialized Certifications:

• Will need to complete IRB coursework.

Physical Requirements:

• Sitting in normal seated position for extended periods of time.
• Ability to use a keyboard and move about.
• Ability to see and hear within normal parameters.
• Ability to walk to perform anthropometric and other testing measures (e.g., ECG, RMR).
• Ability to perform phlebotomy.

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 8:30-4:30 
Exempt Status: Exempt 
Location: Hybrid/JH at Greenspring Station 
Department name: SOM DOM General Internal Medicine 
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.

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