Clinical Research Safety Associate
Clinical Research Safety Associate
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Job Description
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The Department of Executive Dean of Research is currently seeking a Clinical Research Safety Associate to work in Miami. The Clinical Research Safety Associate (CRSA) supports and assists with safety management and reporting of University of Miami sponsored clinical trials within the InvestigatorInitiated Trial Services at the University of Miami. This role involves reviewing and evaluating serious adverse event reports (SAERs) and Adverse Events of Special Interest (AESI) to ensure compliance with regulatory reporting requirements maintaining adverse event data in safety databases and drafting narratives. Responsibilities include collaborating with stakeholders to gather additional safety information preparing regulatory safety reports monitoring safety literature and contributing to developing safety policies and risk management plans. The CRSA works closely with clinical research regulatory affairs and pharmacovigilance teams to maintain the safety and compliance of investigational products.
CORE RESPONSIBILITIES
Review and evaluate Serious Adverse Event Reports (SAERs) and Adverse Events of Special Interest (AESIs) for compliance with regulatory reporting and funding entity requirements.
nsure that reported SAER and AESI event reports are received tracked evaluated processed and distributed/submitted in an efficient and timely manner and in compliance with regulations funding entities requirements and IITSU Safety Management Plans/SOPs.
Generate appropriate queries for study teams to complete and clarify SAE information as needed.
Ensure consistency in investigator causality assessment of SAERs source documentation and Reportability Assessment Forms (RAFs) for completeness accuracy and legibility.
Maintain accurate and uptodate safety information in safety databases and trackers to ensure proper documentation for audits and inspections.
Draft comprehensive and clear narratives for adverse events to support regulatory submission and study records.
Prepare safety reports including MedWatch and CIOMS forms for submission to regulatory authorities and funding entities in a timely and accurate manner.
Prepare safety documentation using requested format by funding entity.
Create and maintain studyspecific SAE or AESI forms for study use.
Draft and maintain study specific comprehensive safety management plans including workflow creation for investigatorinitiated trials to ensure consistent safety oversight.
Contribute to the creation and refinement of safety Standard Operating Procedures (SOPs) and risk management plans to align with Good Clinical Practices.
Assist with training of study team members on the safety reporting expected for the study including how to complete SAE and/or AESI forms timelines associated with completing the forms and how to respond to associated queries on the data submitted.
Participate in the standardized setup of new safety databases.
Help in compiling safety data required for Project Status Reports DSMC meetings and other requests as applicable.
Perform SAE reconciliation.
Liaise with other units and departments.
Participate in inspectionreadiness activities including documentation needed for eTMF.
Support the Medical Monitor in the review and development of written materials including clinical trial protocols SAE and AESI reporting forms and Reportability Assessment Forms.
Inform study team of safety related issues and potential trends and or signals arising from review of data
This list of duties and responsibilities is not intended to be allinclusive and may be expanded to include other duties or responsibilities as necessary.
MINIMUM REQUIREMENTS
Education:
Bachelorsdegree in healthcare science or related field required. Mastersdegreeor higher preferred.
Certification and Licensing:
Clinical research certification ( SOCRA) preferred
Experience:
Minimum 1 year of experience with clinical trials (involving biologics or devices) required. Experience working as a clinical research monitor preferred
The University of Miami offers competitive salaries and a comprehensive benefits package including medical dental tuition remission and more.
UHealthUniversity of Miami Health System South Floridas only universitybased health system provides leadingedge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center we are proud to serve South Florida Latin America and the Caribbean. Our physicians represent more than 100 specialties and subspecialties and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching research and patient care. Were the challenge youve been looking for.
The University of Miami is an Equal Opportunity Employer Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full timeEmployee Type:
StaffPay Grade:
A10Required Experience:
IC
Employment Type
Full-Time
