Clinical Research Safety Associate - Hybrid, Miami FL
University of Miami
- # Clinical Research Safety Associate - Hybrid, Miami FLApplyremote type: Hybridlocations: Miami, FLtime type: Full timeposted on: Posted Todayjob requisition id: R100098284**Current Employees:**If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.The Department of Executive Dean of Research is currently seeking a Clinical Research Safety Associate to work in Miami.**CORE JOB SUMMARY**The Clinical Research Safety Associate (CRSA) supports and assists with safety management and reporting of University of Miami sponsored clinical trials within the Investigator-Initiated 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 IITS-U 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 up-to-date 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 study-specific SAE or AESI forms for study use.* Draft and maintain study specific comprehensive safety management plans, including workflow creation, for investigator-initiated 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 set-up 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 inspection-readiness 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 all-inclusive and may be expanded to include other duties or responsibilities, as necessary.*****CORE QUALIFICATIONS****Education:**Bachelor’s degree in health care, science or related field required. Master’s degree or higher preferred.**Certification and Licensing:**Clinical research certification (e.g. ACRP, SOCRA) preferred**Experience:**Minimum 4 years of experience with clinical trials (involving drugs, biologics or devices) required. Experience working as a clinical research monitor preferred**Knowledge, Skills and Attitudes*** Strong knowledge of Good Clinical Practice (GCP), FDA regulatory requirements and ICH-GCP guidelines* Excellent English skills, both verbal and written* Excellent interpersonal and team skills* Strong attention to detail, time/project management and organization skills* Strong Microsoft Office (Excel, Outlook, PowerPoint, Word) skills* Proficiency in medical data analysis and interpretation.* Proficiency in using clinical trial management software.The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge 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 sub-specialties, 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. We're the challenge you've been looking for.The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.**Job Status:**Full time**Employee Type:**Staff
- J-18808-Ljbffr University of Miami
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Clinical Research Safety Associate - Hybrid, Miami FL in Miami, FL vacancy
- The University of Miami is seeking a Clinical Research Associate 3 for a full-time role in Miami, FL. This position involves coordinating complex clinical research protocols and managing patient referrals in Psychiatry. Ideal candidates should possess a Bachelor’s degree...SuggestedFull time
- ...Technician job at Compunnel Inc. Miami, FL. Core Functions Perform... ...Perform all tasks related to clinical sample testing (blood, urine)... ...as needed Adhere to existing safety standards and help improve laboratory... ...assigned. Core Requirements Associate Degree- with 3 years’...Suggested
- IVFMD-Miami IVFMD - Miami | 730A 7300 SW 62nd Place 4th Floor Miami, FL 33143, USA Under supervision of the Embryology Supervisor... ...II performs basic technical/clinical and research duties independently, as well... ...as well as comply with all safety policies. Meets quality...SuggestedExtra incomeFull timeWork experience placementWeekend work
- ...Clinical Research Associate - Cross Therapeutic Area - Miami ICON is a global healthcare intelligence and clinical research... ...compliance records Monitor patient safety, ensuring timely and accurate AE/... ...to candidates residing in Miami, FL near major HUB airports to...SuggestedLocal areaVisa sponsorship
$40.9k - $69.5k
Clinical Lab Technician I (Fixed-Term Contract) - (English/Spanish) - Miami, FL Syneos Health® is a leading fully-integrated life sciences services organization built to... ...power the science behind advancing clinical research. Why You’ll Love This Role Make a real impact...SuggestedContract workFixed term contractFlexible hoursShift workNight shiftDay shiftAfternoon shift$40.9k - $69.5k
Clinical Lab Technician I (Per diem Contract) - (English/Spanish) - Miami, FL Updated: Today Location: Miami, FL, United States Job ID: 25108908 Syneos Health® is a leading... ..., documentation, and consistency in clinical research. Strong communicator: bilingual in English...Daily paidContract workFlexible hoursShift workNight shiftDay shiftAfternoon shift$65 - $90 per hour
C-Clinical is seeking a Senior Clinical Research Associate to support clinical trials throughout the Miami region. This opportunity is ideal for an experienced clinical research professional... ...while supporting data quality, patient safety, and study timelines across multiple...Hourly payRemote work- The University of Miami is seeking a full-time Research Assistant 3 in Miami, FL. This role includes planning and implementing research experiments, recruiting and... ...research team and engage in cutting-edge clinical research. #J-18808-Ljbffr University of MiamiFull time
- Myana is looking for a Senior Clinical Research Associate to support clinical trials in the Miami region. This role allows for both remote responsibilities and routine on-site monitoring, enabling direct interaction with investigative teams. The ideal candidate has five...Remote job
- ...here to view live vacancies. Clinical Research Associate ICON plc is a world-leading healthcare... ...obesity trials. Must be located in Miami, FL. What You Will Do: You will... ..., data integrity, and patient safety throughout the trial process. Collaborating...Remote jobFlexible hours
- The University of Miami is seeking a Full Time Research Laboratory Technician to support scientists at the UHealth Medical Campus in Miami, FL. Responsibilities include maintaining lab equipment... ...research data, and complying with safety regulations. Ideal candidates will...Full time
- Clinical Research Associate - Cross Therapeutic Area - Miami ICON plc is a world-leading healthcare intelligence and clinical... ...records Monitor patient safety, ensuring timely and accurate AE/... ...to candidates residing in Miami, FL near major HUB airports to support...Local areaVisa sponsorshipFlexible hours
ICON plc
Miami, FLa month ago - ...Water Sampling Technician to support a federal contract at the Miami VA Healthcare System. This role involves collecting water samples... ...business hours Work performed at VA Medical Center and associated facilities Monthly and quarterly sampling events required...Contract workPart timeMonday to Friday
$96.2k - $151.4k
...Clinical Research Associate Candidate must reside in one of the following locations and be fluent in... ...Spanish: South Florida - Ft. Lauderdale, Miami, Boca Raton, Key Largo. The role is... ...and unbiased. Subjects' right, safety and well-being are protected. Conducts...Remote jobLocal area2 days per week3 days per week- Clinical Research Associate - Cross Therapeutic Area - Miami ICON plc is a world‑leading healthcare intelligence and clinical research... ...records Monitor patient safety, ensuring timely and accurate AE/... ...to candidates residing in Miami, FL near major HUB airports to support...Local areaVisa sponsorshipFlexible hours
- ...Temporary employee at the University of Miami, please click here ( to log in to Workday... ...an exciting opportunity for a Full Time, Research to work in Miami. Core Job Summary:The... ...ensures laboratory compliance with applicable safety regulations. Core Responsibilities:...Full timeTemporary workWork experience placementWorldwideNight shiftWeekend workAfternoon shift
University of Miami
Miami, FL18 hours ago - Cardiovascular Associates of America is seeking a Clinical Research Assistant in Miami, Florida. The role involves coordinating participant appointments, processing biological specimens, and maintaining study documentation. The ideal candidate should have a High School...Work at office
- Research Laboratory Technician The University of Miami/UHealth department of Research Laboratory Technician has an exciting opportunity for a Full Time Research... ...ensures laboratory compliance with applicable safety regulations. Cleans, sanitizes, maintains, and operates...Full timeWork experience placementWork at officeWorldwide
- Research Laboratory Technician page is loaded## Research Laboratory Technicianremote type: Hybridlocations: Miami, FLtime type: Full timeposted on: Posted Todayjob requisition id: R1000962... ...laboratory compliance with applicable safety regulations.* Cleans, sanitizes,...Full timeTemporary workWork experience placementWork at officeWorldwide
- Naturalist page is loaded## Naturalistlocations: North Miami Beach, FLtime type: Full timeposted on: Posted Yesterdayjob requisition id... ...Perform duties as First Mate to Captain, which may include the safety talk prior to vessel leaving the dock.* Educate and inform guests...Weekend workAfternoon shift
- Compunnel Inc. in Miami, FL is seeking a Laboratory Technician to perform reagent... ...environment. You will handle clinical samples (blood, urine) from... ...maintaining inventory and enforcing safety standards. The role requires an Associate degree with 3 years’ experience or...
- ...Laboratory Technician Full Time CPMI-Clinical Pharmacology Miami, Miami, FL, US 3 days ago Requisition ID: 1416 About Company: Evolution Research Group (ERG) is dedicated to delivering... ..., and medication history. Complete safety assessments Work closely and collaboratively...Full time
- Clinical Laboratory Technician (Per diem) Miami, FL, USA Job Description Quotient Sciences: Molecule to Cure. Fast. Quotient Sciences is a leading drug development... ...Clinical Practice (GCP) standards Ensures subject safety at all times Main Tasks and Responsibilities...Daily paidLocal area
- ...001 - Northern Gulf Institute Location: Miami, FL Categories: Professional Position Open Date... ...being disagreeable. May involve minor safety hazards where likely result would be... ...shallow waters, or work aboard small boats or research vessels. Equal Employment Opportunity...Full timeFor contractorsWork at officeImmediate start
- Lake Roosevelt Adventures in Miami, Florida is hiring a Boat Naturalist to educate passengers on our 90-minute boat tours, monitor their comfort and safety, and assist the Captain as First Mate. The role involves engaging with guests about local wildlife, ensuring sanitation...Local area
- Quotient Sciences in Miami is seeking a Clinical Research Technician - Phlebotomist to collect biological samples and ensure patient safety. The role involves performing phlebotomy, maintaining study schedules, and adhering to Good Clinical Practice standards. The ideal...Daily paid
- C-Clinical is seeking a Senior Clinical Research Associate to support clinical trials throughout the Miami region. The position combines remote responsibilities with routine on‑site monitoring... ...while supporting data quality, patient safety, and study timelines across multiple...Contract workFor contractorsRemote work
- Ergclinical is seeking a Research Assistant for the day shift in Miami, FL. The role involves ensuring compliance with protocol and clinical objectives guided by FDA regulations and good clinical practices. Responsibilities include preparing source documents, performing...Work at officeDay shift
- Evolution Research Group seeks an Assistant Coordinator to support clinical research studies across CNS and other therapeutic areas. You will assist with data collection... ..., with a focus on quality data and participant safety in a fast-paced setting. #J-18808-Ljbffr...
- A clinical research organization in Miami is seeking a Clinical Research Support professional to assist with various clinical trials. Responsibilities include supporting the clinical study team, monitoring studies, preparing reports, and assisting with protocol development...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Clinical Research Safety Associate - Hybrid, Miami FL. Be the first to apply!
Related searches
- clinical research administrator Miami, FL
- clinical trials assistant Miami, FL
- clinical research assistant Miami, FL
- clinical research associate no experience Miami, FL
- clinical research associate Miami, FL
- on-site clinical research associate (traveling/remote) Miami, FL
- clinical research director Miami, FL
- clinical research trainee Miami, FL
- clinical research manager remote Miami, FL
- clinical research monitor Miami, FL