The Transplant Oncology and Infectious Diseases Clinical Research Center (TOID CRC) is looking for an experienced Research Nurse Safety Reporting Specialist 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.
Minimum Qualifications (Mandatory):
Bachelor's Degree in Nursing or related science.
Requires a minimum of two years related research experience.
Must have clinical trials experience.
Minimum of two years' experience in nursing preferred.
Hospital clinical research; transplant/oncology patients, REDCap experience, experience with MedDRA coding is preferred.
Licensure, Certification, Registration:
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing.
Must maintain current licensure and certification during duration of employment.
Acceptable completion of the JHH or BMC credentialing process is required within two weeks of start date.
Special Knowledge, Skills & Abilities:
Exceptional written and verbal communication skills.
Ability to work as part of a team, proficiency in Microsoft Office Suite, meticulous record keeping.
Required work schedule 5 days per week plus on-call weekends approximately 1-2 weekend a month plus rotating holiday.
On-call is remote.
Classified Title: Research Nurse Working Title: Research Nurse Safety Reporting Specialist Role/Level/Range: ACRP/03/ME Starting Salary Range: $61,550 - $84,700 annually (commensurate with experience) Employee group: Full Time Schedule: Mon-Friday 8:30am-5pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM DOM 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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