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Joppa, Maryland
Posted: 02-May-23
Location: Baltimore, Maryland
Salary: Open
Internal Number: 108969-en_US
The Department of Surgery is seeking a Sr Research Program Coordinator to support cardiac surgery clinical trials and is a critical component to the success for the cardiac surgery clinical trials program. The coordinator will be responsible for the overall implementation and coordination of clinical trials from study start-up to study close-out.
Specific Duties & Responsibilities
- Collaborate with research team on scientific implementation, daily operation, and data management of interventional clinical trials.
- Screen participants for studies, including complex procedural and interventional studies.
- Conduct study participant visits, including inpatient wards and outpatient clinics.
- Provide for the acquisition and processing of clinical samples from study participants.
- Maintain study level documentation for assigned studies.
- Prepare for and participate in study monitoring visits.
- Prepare documents, annual reports, and amendments required by the FDA and IRB.
- Under the direction of surgeon principal investigators, determine patient study eligibility, obtain informed consent, and initiate patient randomization and enrollment.
- Ensure protocol adherence, schedule patient visits and assessments, perform data entry into study databases.
- Act as a liaison for various studies with sponsors, study monitors, patients and their providers.
- Participate in staff meetings to report on screening, recruitment, and data collection progress and resolve problems.
- Work under the direction of the Principal Investigators and Clinical Research Program Administrator to ensure successful completion of clinical research projects.
- May be required to travel to satellite locations.
- Adhere to FDA regulatory compliance and regulations.
- Ensure quality, consistency, and accuracy in the conduct of research trials.
- Oversee budget development, as well as budget expenditures for study operations.
- Conduct all study close-out related procedures including IRB termination reports.
Minimum Qualifications
- Bachelor's Degree in related discipline.
- Three years related experience.
- Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
The Department of Surgery is seeking a Sr Research Program Coordinator to support cardiac surgery clinical trials and is a critical component to the success for the cardiac surgery clinical trials program. The coordinator will be responsible for the overall implementation and coordination of clinical trials from study start-up to study close-out.
Specific Duties & Responsibilities
- Collaborate with research team on scientific implementation, daily operation, and data management of interventional clinical trials.
- Screen participants for studies, including complex procedural and interventional studies.
- Conduct study participant visits, including inpatient wards and outpatient clinics.
- Provide for the acquisition and processing of clinical samples from study participants.
- Maintain study level documentation for assigned studies.
- Prepare for and participate in study monitoring visits.
- Prepare documents, annual reports, and amendments required by the FDA and IRB.
- Under the direction of surgeon principal investigators, determine patient study eligibility, obtain informed consent, and initiate patient randomization and enrollment.
- Ensure protocol adherence, schedule patient visits and assessments, perform data entry into study databases.
- Act as a liaison for various studies with sponsors, study monitors, patients and their providers.
- Participate in staff meetings to report on screening, recruitment, and data collection progress and resolve problems.
- Work under the direction of the Principal Investigators and Clinical Research Program Administrator to ensure successful completion of clinical research projects.
- May be required to travel to satellite locations.
- Adhere to FDA regulatory compliance and regulations.
- Ensure quality, consistency, and accuracy in the conduct of research trials.
- Oversee budget development, as well as budget expenditures for study operations.
- Conduct all study close-out related procedures including IRB termination reports.
Minimum Qualifications
- Bachelor's Degree in related discipline.
- Three years related experience.
- Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Classified Title: Sr. Reseach Program Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $40,100-$55,140-$70,180 Annually (Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8-4:30
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM Sur Cardiac Surgery
Personnel area: School of Medicine
Total Rewards
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. 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.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.
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
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf
Accommodation Information
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. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
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.
Note: Job Postings are updated daily and remain online until filled.
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