Job Overview:
The Senior Clinical Research Associate II (Sr CRA II) is responsible and accountable for site monitoring and site management for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Sr CRA II assures the implementation of project plans as assigned, functions as leader for projects of limited scope, as assigned and assumes line management responsibilities, as assigned. Acts in the project role of a Local Project Coordinator or Lead CRA as assigned.
Must be based in well connected cities, preferably Rome or Milan Area.
Summary of Responsibilities:
- The statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
- 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 audit readiness at the site level.
- Travel, including air travel, may be required and is an essential function of the job.
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
- Conduct, report, and follow-up on Quality Control (QC) visits when requested.
- 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.
- 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.
Qualifications (Minimum Required):
- Mandatory: University or college degree, 5 years Master's Degree in Scientific or Medical Field; CRA certification in line with Ministerial Decree of November 15, 2011.
- In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.
- Thorough knowledge of regulatory requirements.
- Thorough understanding of the drug development process.
- Fluent in local office language and in English, both written and verbal.
- Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirement.
Experience (Minimum Required):
- Mandatory Five years site monitoring and/or site management experience. A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Advanced site monitoring and 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.
Preferred Qualifications Include:
- Thorough knowledge of company SOPs regarding site monitoring.
- Minimum 1 Year 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.
- Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
- Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
- Methodical approach to work.
- Strong understanding of medical and clinical research terminology, and clinical research processes.
- An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
- Strong understanding of the principles of regulatory requirements.
- Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications.
- Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
- Experience using a clinical trial management system (CTMS).
- For medical device positions, experience in providing customer service to device end users.
The base salary range for this role is € 47,800 - 63,000 gross per year, which may vary as per working schedule (full or part-time). The final offer will be determined based on objective and job-related criteria such as experience, qualifications, and scope of responsibilities, in line with our internal job classification framework and the applicable collective labour agreement (CCNL). This role may also be eligible for additional compensation, such as bonus and benefits, in accordance with company policies.
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