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.
Summary of Responsibilities:
- 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 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.
- Prepare accurate and timely trip reports.
- 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.
- 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.
- Conduct, report, and follow-up on Quality Control (QC) visits when requested.
- 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.
Qualifications (Minimum Required):
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure), an equivalent amount of experience can be substituted as appropriate.
- In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered. Plus Mandatory experience of minimum 2 years in one of the following areas: Oncology, Ophthalmology, and/or Gene Therapy.
- Thorough knowledge of regulatory requirements.
- Thorough understanding of the drug development process.
- Fluent in local office language and in English, both written and verbal.
Experience (Minimum Required):
- Five years of Clinical Monitoring experience. Plus Mandatory experience of minimum 2 years in one of the following areas: Oncology, Ophthalmology, and/or Gene Therapy.
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Good computer skills with good working knowledge of a range of computer packages
- Ability to train and supervise junior staff.
- Ability to resolve project-related problems and prioritizes workload for self and team.
Physical Demands/Work Environment:
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