The Transplant Oncology and Infectious Diseases Clinical Research Center (TOID CRC) is looking for an experienced Research Nurse to be a part of the clinical research safety reporting team. Our research focuses on solid organ transplantation and in particular novel transplantation practices such as organ donation from donors with HIV and hepatitis C. We are also studying COVID -19 in the transplant recipient population. The TOID CRC is responsible for the oversight and management of numerous multi-centered national and international clinical trials.
Specific Duties & Responsibilities:
Case and Event Review and Reporting
Reviews clinical narratives related to Adverse Events (AEs) and Serious Adverse Events (SAEs) reported to the TOID Clinical Research Center.
Help develop common clinical queries for AEs and SAEs according to each protocol's severity grading and relationship to study intervention.
Initiate data clarification queries to partner clinical sites about reported adverse events and track each to resolution.
Ability to apply knowledge of pathophysiology and pharmacology to assist in the development of case report forms.
Code AEs and SAEs according to a standard coding system and upload reports through each reporting system as defined in protocol's safety management plan.
Collaborate with TOID Research staff members to develop comprehensive safety management plan for each new protocol.
Assist with the preparation of routine and ad hoc safety reports for review by internal and external safety monitoring boards.
Demonstrate knowledge of safety concepts, per FDA guideline for IND safety reporting.
Prepare IND reports for submission to the FDA.
Assist in the development of standard operating procedures and regulatory policy for the Center.
Must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline preferred. Current American Heart Association or American Red Cross CPR certification required. Must maintain current licensure and certification during duration of employment. Acceptable completion of the JHH credentialing process.
Additional Knowledge, Skills, and Abilities:
Minimum of two years' experience in nursing.
Requires a minimum of two years related research experience.
Must have clinical trials experience.
Hospital clinical research; transplant/oncology patients, REDCap experience, experience with MedDRA coding is preferred.
Exceptional written and verbal communication skills, ability to work as part of a team, proficiency in Microsoft Office Suite, meticulous record keeping.
Working Conditions /Additional Requirement for the Position:
Travel required: Approximately 6 days/month. Provide 24/7 pager support to study centers. Approximately 1 week/month.
Required work schedule 5 days per week plus on-call weekends approximately 1-2 weekend a month plus rotating holiday.
On-call is remote.
Position requires significant mobility, ability to walk back and forth between university, lab, and hospital. Must be able to lift 10 pounds overhead, and pickup and carry objects up to 15 pounds.
Sitting, standing and walking for extended period. 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). Ability to move standard equipment through a hospital or clinical environment.
Classified Title: Research Nurse Working Title: Research Nurse Monitoring Specialist Role/Level/Range: ACRP/03/ME Starting Salary Range: $61,550.00 - $84,700.00 Annually; Commensurate with experience Employee Group: Full Time Schedule: Monday - Friday, 8:30am - 5:00pm; On-call weekends approximately 1-2 weekend a month; rotating holiday. Exempt Status: Exempt Location: School of Medicine Campus Department Name: Medicine, Infectious Disease Personnel Area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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