Sr. Research Program Coordinator II #Staff

Job description

The Division of Pulmonary and Critical Care Medicine and Director of the Medical Intensive Care Unit (ICU) is seeking a **_Sr. Research Program Coordinator II_** who will have duties and responsibilities related to coordinating and supporting the research efforts of the JH ICU Clinical Trials Group and participating principal investigators (PI).

The JH ICU Clinical Trials Group is focused on clinical trials that investigate therapeutic interventions for different critical illness syndromes including sepsis, acute respiratory failure, acute respiratory distress syndrome, liver failure, and renal failure.

Interventions may include new therapeutic drugs, devices, or strategies.

Most interventions for these trials begin in the ICU, with close follow-up for 2 to 4 weeks and longer term follow up at 28 and/or 90 days.

Each trial is a little different depending on the intervention being studied.

Most will include collection of biospecimens that will need on-site processing before being stored and then shipped to a central lab at a later date.

**Specific Duties & Responsibilities**

+ Work closely with the Principal Investigators on studies to ensure timely, accurate submission to the IRB of studies applications.
+ Assure study protocols have complete, consistent language throughout.

Follow up the status and identify bottlenecks in the approval processes.
+ Obtain all required documents for study submissions to the IRB.
+ Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.
+ Analyze data and contribute to writing draft or sections of manuscripts.
+ Develop and maintain study documents such as laboratory manuals.
+ Internally monitor regulatory files and study data to assess compliance, data quality, and accuracy.
+ Complete IRB amendment submissions and ensure documentation of training.
+ Attend study start up meetings for all studies, and present data at meetings as needed.
+ Produce and maintain a regulatory binder prior to study starting with all required documents.
+ Work closely with Principal Investigators to ensure all documents are reviewed, approved and correct prior and during the study.
+ Ensure all documents are being collected in a timely manner and all regulatory binders are up to date.
+ Assist with study monitoring/auditing requirements.
+ Participate in development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
+ Conduct training sessions for lower level program coordinators working at other locations within multi-centered clinical trial.
+ Develop standard operating procedures for regulatory submissions as needed.
+ Maintain a continued high level of expertise in institutional databases including REDCap, OpenSpecimen, EPIC, Oncore, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
+ Review and analyze studies for difficulties that may arise with study processes and procedures.

Suggest appropriate alternatives to possible complications.
+ Complete minimum requirements for continuing education units.

Maintain up to date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies.

Teaches staff about regulatory aspects.
+ Updates faculty on regulatory study status.
+ Provide complex project support to the faculty including assistance with grant application and progress report, translational research protocols and important correspondence, and project management.

This person will deal regularly with highly sensitive, privileged and confidential subject matter.
+ Edit presentations.
+ Coordinate and manage communications work with internal and external entities.
+ Oversight of study budgets and contracts processing through ORA to assure execution and completion in a timely manner.
+ If needed and as time permits, support data collection and entry related to research studies.
+ If needed and as time permits, help with participant enrollment in research studies.
+ If needed and as time permits, transport biospecimens to lab for processing.

**Minimum Qualifications**

+ Bachelor's Degree in related discipline.
+ Five years related experience.

**Preferred Qualifications**

+ Master's Degree
+ Experience in budget generation, contractual process and financial management of clinical trials.
+ Experience in clinical research and regulatory affairs.
+ Experience in protocol and informed consent writing, data analysis, grant writing, and /or manuscript preparation.
+ Knowledge of research methodology and working knowledge of computers.

Classified Title: Sr. Research Project Coordinator II
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $48,000 - $84,100 ($63,000 Targeted; Commensurate w/ exp.)
Employee group: Full Time
Schedule: Monday to Friday 8:30 am - 5pm
FLSA Status: Exempt
Location:School of Medicine Campus
Department name: SOM DOM Pulmonary
Personnel area: School of Medicine
The listed salary range represents the minimum and maximum Johns Hopkins University offers for this position, based on a good faith estimate at the time of posting.

Actual compensation will vary depending on factors such as location, skills, experience, market conditions, education, and internal equity.

Not all candidates will qualify for the highest salary in the range.
Johns Hopkins provides a comprehensive benefits package supporting health, career, and retirement.

Learn more: https://hr.jhu.edu/benefits-worklife/.
Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Required Skill Profession

Other General