Fortrea
Overview
We are currently seeking experienced Oncology CRAs residing in Florida to join our FSP team. Job title: FSP - Sr. CRA - Oncology - Florida, at Fortrea. Note:
Apply details, dates, and applicant counts in the original posting may be left out if not relevant to the job description; this refinement keeps the core responsibilities and qualifications. Responsibilities
The Senior CRA I is responsible for site monitoring and site management in accordance with Fortrea and sponsor SOPs and regulatory guidelines. The Senior CRA I ensures implementation of project plans and may act as a leader for projects of limited scope. May assume line management responsibilities and act as Local Project Coordinator or Lead CRA as assigned. Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned. Responsible for all aspects of site management as prescribed in the project plans. General On-Site Monitoring Responsibilities: ensure study staff have proper materials and instructions to safely enter patients into the study and that informed consent and protocol requirements are followed per regulatory requirements. Ensure the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source data review; monitor data for missing or implausible data. Manage resources efficiently (SOPs and guidelines) including travel expenses according to Fortrea travel policy. Ensure audit readiness at the site level; travel may be required and is an essential function of the job. Prepare accurate and timely trip reports; manage small projects under the direction of a Project Manager/Director as assigned. Serve as lead monitor for a protocol or project and assist in establishing monitoring plans and trip report review as assigned; review progress and initiate actions to achieve objectives. Organize and present at Investigator Meetings; participate in protocol and Case Report Form development; participate in writing clinical trial reports as assigned. Interact with internal work groups to evaluate needs, resources, and timelines; act as contact for clinical trial supplies and other vendors as assigned. Responsible for all aspects of registry management as prescribed in project plans; undertake feasibility work when requested; conduct, report, and follow-up on Quality Control (QC) visits when requested. Recruit investigators and handle regulatory submissions and translations; organize meetings and other tasks as instructed; negotiate study budgets with investigators and assist Fortrea legal department as assigned. Track and follow-up on Serious Adverse Event (SAE) reporting; produce SAE reports, narratives, and follow-up. Independently perform CRF review, query generation, and resolution against data review guidelines on Fortrea or client data management systems; assist with training and mentoring of new employees. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as local client contact; perform other duties as assigned. Qualifications (Minimum Required)
University or college degree (life science preferred) or certification in a related allied health profession; nursing certification, medical or laboratory technology from an accredited institution. In lieu of education, a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered. Thorough knowledge of regulatory requirements including basic understanding of regulatory requirements in other countries; thorough understanding of the drug development process; fluent in local office language and English (written and verbal). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required)
Three (3) years of Clinical Monitoring experience. Full understanding of Serious Adverse Event (SAE) reporting and follow-up; advanced site monitoring and registry administration skills. Ability to work with minimal supervision; strong planning, organization, and computer skills; advanced verbal and written communication; ability to train and supervise junior staff. Ability to resolve project-related problems, prioritize workload, and work within a matrix project team; valid driver’s license. Preferred Qualifications Include
One (1) or more years of additional experience in related fields (medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing). Local project coordination and/or project management experience. Physical Demands/Work Environment
Travel requirements: 60-80% overnight. Office/Home-Based
Work environment includes office setting with exposure to electrical equipment; occasional drives to site locations with domestic and international travel. Physical Requirements
Frequently stationary for 6-8 hours per day; repetitive hand movements; occasional crouching and twisting; ability to lift up to 15-20 lbs; regular attendance and varied hours may be required. Target Pay Range (based on title): $120-133K Learn more about our EEO & Accommodations request here. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Fortrea by 2x DeLand, FL Clinical Research Technician I / Daytona Beach, FL (ON-SITE) – posting details provided in original
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We are currently seeking experienced Oncology CRAs residing in Florida to join our FSP team. Job title: FSP - Sr. CRA - Oncology - Florida, at Fortrea. Note:
Apply details, dates, and applicant counts in the original posting may be left out if not relevant to the job description; this refinement keeps the core responsibilities and qualifications. Responsibilities
The Senior CRA I is responsible for site monitoring and site management in accordance with Fortrea and sponsor SOPs and regulatory guidelines. The Senior CRA I ensures implementation of project plans and may act as a leader for projects of limited scope. May assume line management responsibilities and act as Local Project Coordinator or Lead CRA as assigned. Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned. Responsible for all aspects of site management as prescribed in the project plans. General On-Site Monitoring Responsibilities: ensure study staff have proper materials and instructions to safely enter patients into the study and that informed consent and protocol requirements are followed per regulatory requirements. Ensure the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source data review; monitor data for missing or implausible data. Manage resources efficiently (SOPs and guidelines) including travel expenses according to Fortrea travel policy. Ensure audit readiness at the site level; travel may be required and is an essential function of the job. Prepare accurate and timely trip reports; manage small projects under the direction of a Project Manager/Director as assigned. Serve as lead monitor for a protocol or project and assist in establishing monitoring plans and trip report review as assigned; review progress and initiate actions to achieve objectives. Organize and present at Investigator Meetings; participate in protocol and Case Report Form development; participate in writing clinical trial reports as assigned. Interact with internal work groups to evaluate needs, resources, and timelines; act as contact for clinical trial supplies and other vendors as assigned. Responsible for all aspects of registry management as prescribed in project plans; undertake feasibility work when requested; conduct, report, and follow-up on Quality Control (QC) visits when requested. Recruit investigators and handle regulatory submissions and translations; organize meetings and other tasks as instructed; negotiate study budgets with investigators and assist Fortrea legal department as assigned. Track and follow-up on Serious Adverse Event (SAE) reporting; produce SAE reports, narratives, and follow-up. Independently perform CRF review, query generation, and resolution against data review guidelines on Fortrea or client data management systems; assist with training and mentoring of new employees. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as local client contact; perform other duties as assigned. Qualifications (Minimum Required)
University or college degree (life science preferred) or certification in a related allied health profession; nursing certification, medical or laboratory technology from an accredited institution. In lieu of education, a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered. Thorough knowledge of regulatory requirements including basic understanding of regulatory requirements in other countries; thorough understanding of the drug development process; fluent in local office language and English (written and verbal). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required)
Three (3) years of Clinical Monitoring experience. Full understanding of Serious Adverse Event (SAE) reporting and follow-up; advanced site monitoring and registry administration skills. Ability to work with minimal supervision; strong planning, organization, and computer skills; advanced verbal and written communication; ability to train and supervise junior staff. Ability to resolve project-related problems, prioritize workload, and work within a matrix project team; valid driver’s license. Preferred Qualifications Include
One (1) or more years of additional experience in related fields (medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing). Local project coordination and/or project management experience. Physical Demands/Work Environment
Travel requirements: 60-80% overnight. Office/Home-Based
Work environment includes office setting with exposure to electrical equipment; occasional drives to site locations with domestic and international travel. Physical Requirements
Frequently stationary for 6-8 hours per day; repetitive hand movements; occasional crouching and twisting; ability to lift up to 15-20 lbs; regular attendance and varied hours may be required. Target Pay Range (based on title): $120-133K Learn more about our EEO & Accommodations request here. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Fortrea by 2x DeLand, FL Clinical Research Technician I / Daytona Beach, FL (ON-SITE) – posting details provided in original
#J-18808-Ljbffr