Apply on Employer Site

Fortrea · 18 hours ago

FSP - Sr. CRA 2 - Cardiology/Electrophysiology Device - Remote US

United States

Full-time

Remote

Senior Level

$135K/yr - $142K/yr

5+ years exp

Fortrea is currently seeking experienced Cardiology Device or Electrophysiology Sr. CRAs to join their FSP team. The Senior CRA II is responsible for site monitoring and management, ensuring compliance with regulatory guidelines and project plans, and may lead small projects as assigned.

Clinical TrialsHealth Care

H1B Sponsor Likely

Responsibilities

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

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review

Monitor data for missing or implausible data

Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy

Ensure audit readiness at the site level

Travel, including air 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 may assist in establishing monitoring plans and trip report review as assigned

Review progress of projects and initiate appropriate actions to achieve target objectives

Organize and make presentations at Investigator Meetings

Participate in the development of protocols and Case Report Forms as assigned

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 suppliers (vendors) as assigned

Responsible for all aspects of registry management as prescribed in the project plans

Undertake feasibility work when requested

Conduct, report, and follow-up on Quality Control (QC) visits when requested

Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned

Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned

Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management

Assist with training, mentoring and development of new employees, e.g., co-monitoring

Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned 29) Perform other duties as assigned by management

All other duties as needed or assigned

Qualification

Clinical MonitoringSite ManagementCardiology Device ExperienceRegulatory KnowledgeSAE ReportingRegistry AdministrationPlanningOrganizationSupervision SkillsComputer SkillsCommunication SkillsTeamworkProblem Solving

Required

University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology

Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries

Thorough understanding of the drug development process

Fluent in local office language and in English, both written and verbal

Fortrea may consider relevant and equivalent experience in lieu of educational requirements

Five (5) years of Clinical Monitoring experience

Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs

Advanced site monitoring skills

Advanced study site management skills

Advanced registry administration skills

Ability to work with minimal supervision

Good planning and organization skills

Good computer skills with good working knowledge of a range of computer packages

Advanced verbal and written communication skills

Ability to train and supervise junior staff

Ability to resolve project-related problems and prioritizes workload for self and team

Ability to work within a project team

Works efficiently and effectively in a matrix environment

Valid Driver's License

Company

Fortrea

Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions.

Founded in 2023

Durham, North Carolina, USA

10001+ employees

https://www.fortrea.com

H1B Sponsorship

Fortrea has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (14)

2024 (25)

2023 (6)