This position is responsible for management, oversight and coordination of research grants and projects led by the Division of Addiction Medicine. These include the CTN 0098A EXHIT ENTRE study and development of Division of Addiction Medicine processes for research operations.
Provides comprehensive study coordination, facilitates project development, and contributes to successful project execution. Requires knowledge of research methodology for working with human subjects and of general research principles. Ability to communicate effectively and develop rapport with research subjects, and the ability to work with accuracy and attention to detail.
Specific duties & responsibilities:
This position will be responsible for management of various projects, working closely with investigators and staff.
The position will set goals and timelines in collaboration with investigators, and ensure timely accomplishment of project tasks and goals with high quality.
Responsibilities will be primarily research-based but will require integration with program operations from Division of Addiction Medicine and clinical operations at Johns Hopkins Bayview Medical Center to ensure successful implementation of studies.
The position is responsible for ensuring program quality, and adherence to expected processes and project goals and timelines.
The position also organizes and ensures effective interaction with external partners, ranging from NIDA Clinical Trials Network to various funding agencies/organizations to the institutional review board and other groups as needed.
Essential Job Functions:
Oversee overall research program implementation, timelines, goals and conduct of related tasks
Collaborate and integrate the research in the operations and program implementation
Conduct meetings and monitor progression toward goals
Triage issues that require input of investigators and other committees to ensure efficient resolution of issues
Prepare, submit and track protocols, amendments, and related documents relevant to appropriate Institutional Review Boards, DSMB, and other oversight groups
Establish appropriate flow of information and materials between meetings and for various study committees; ensure setting of investigator meetings and communications across all participants
Ensure timely accomplishment of project tasks and goals with high quality
Provide oversight of budget expenditures and tracking of project funds together with the Principal Investigator, and budget analyst
Coordinate all study activities at the site including, but not limited to, coordinating study team, implementing and monitoring, recruitment, and retention efforts, developing tools to track site progress toward study goals, and may assist with site budget and regulatory files maintenance.
Develop Standard Operating Procedures (SOPs) in order to implement the protocol and procedures at the local site.
Proactively anticipate implementation problems and work with Site PI and research team to prevent and devise solutions to problems.
Oversee day-to-day activities of research assistant and other study staff
Serve as back-up to the RA or other staff, as appropriate.
Attend and participate in study monitoring visits, meetings, and conference calls, providing site-specific information as required.
Recruits, identifies, and interviews participants.
Obtain informed consent
Schedule and conduct study visits
Administer and score psychological, intellectual, and/or other assessments and tests per protocol or project.
Set-up and operate various scientific apparatus and systems to gather patient reported outcomes as required by the protocol or project.
Preparing specimens for laboratory testing and/or shipping, tracks collected specimens as defined by the protocol or project.
Obtain biological specimens including urine specimens
Coordinate delivery and analysis of biological samples with laboratory personnel
Accurately disburse funds to study participants
Routinely coordinate daily activities associated with administering sponsored research projects.
Organize meeting and conference calls
Meeting minutes and distribution
Be proactive in identifying problems and devising solutions
Documents and consistently maintains detailed records and research data files.
Assist with data entry and data cleaning
Reviews data quality and accuracy on a regular basis
Produce routine reports
Schedule training as needed
Compile and maintain regulatory documents.
Work with local IRB, other IRBs, and investigators to obtain and maintain regulatory approvals
Track study supplies.
To include equipment, study materials, drug/equipment supply as necessary
Maintain supply inventory by checking stock to determine inventory level; anticipating needs; verifying receipt of supplies.
Support the Research Project Manager and/or PI as requested
Address participant problems and concerns
Assist in training of research assistants and staff if required.
Provide back-up coverage for other staff if the need arises.
Handle and protect confidential and sensitive data with integrity.
Minimum qualifications (mandatory):
Bachelor's degree in related discipline.
3 years related experience (related area and/or research).
Additional education may substitute for required experience and additional related experience may substitute for required educations, to the extent permitted by the JHU equivalency formula.
Master's degree (or equivalent degree) in related discipline. Experience working with substance use disorders.
Special knowledge, skills, and abilities:
Requires interaction with a diverse population.
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
Regular contact with researchers and collaborators requires the use of good judgment, tact and sensitivity; Excellent organizational and time management skills required
Excellent interpersonal skills
Excellent oral and written communication skills required
Excellent attention to detail; Ability to manage multiple and competing priorities
Proficiency in the use of standard software applications, databases, spreadsheets and word processing required.
Classified Title: Sr. Research Program Coordinator Working Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920 - $53,520 Employee group: Full Time Schedule: M-F 8:30-5:00 Exempt Status: Exempt Location: 33-MD:Johns Hopkins Bayview Department name: 10002787-SOM DOM Bay Chemical Dependency 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 protected]. 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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