Sr CRA

Fortrea

Oct 31, 2024

Job
Full-time
Mid Level
Research & Development
Healthcare
Milan
Remote
Quick Apply

AI generated summary

You need a relevant degree or 3+ years of clinical research experience, CRA certification, strong monitoring skills, and fluency in local language and English.
You will monitor clinical sites, ensure protocol compliance, perform data reviews, manage budgets, report on adverse events, and mentor new employees, with 60-80% travel required.

Requirements

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.
CRA Certification as per Ministerial Decree
In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.
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.
Mandatory 3-4 years of Clinical Monitoring experience or currently holding the role of CRA II
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.
One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
Local project coordination and/or project management experience.

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.
Perform other duties as assigned by management.
All other duties as needed or assigned.
Travel requirements: 60-80% overnight.

FAQs

What is the role of a Senior CRA at Fortrea?

The Senior CRA is responsible for site monitoring and site management, ensuring that clinical studies adhere to Fortrea and Sponsor Standard Operating Procedures and Regulatory Guidelines.

Is this position currently available?

This role is for upcoming future opportunities that may arise at Fortrea.

What are the primary responsibilities of the Senior CRA?

Responsibilities include site monitoring and management, maintaining study files, conducting site visits, liaising with vendors, and ensuring compliance with regulatory requirements.

What qualifications are required for this position?

A university or college degree in a life science field or a related health profession is preferred, along with CRA certification. Alternatively, candidates with at least 3 years of relevant clinical research experience may also be considered.

How many years of experience are required for this role?

A minimum of 3-4 years of clinical monitoring experience is mandatory.

What languages must a candidate be fluent in?

Candidates must be fluent in the local office language and in English, both written and verbal.

Is travel required for this position?

Yes, travel is required and may involve 60-80% overnight travel.

What skills are important for a Senior CRA?

Important skills include advanced site monitoring and management skills, planning and organization skills, effective communication skills, and the ability to work with minimal supervision.

Does Fortrea encourage diversity in hiring?

Yes, Fortrea is committed to diversity and inclusion within the workforce and does not tolerate discrimination of any kind.

Can candidates without a specific degree still apply?

Yes, candidates with a minimum of 3 years of relevant clinical research experience in the pharmaceutical or CRO industries may be considered regardless of their degree.

Fortrea

Science & Healthcare

Industry

10,001+

Employees

2023

Founded Year

Mission & Purpose

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.