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.
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.
* 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 needed or assigned.
Qualifications
* University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). Equivalent experience may be substituted as appropriate.
* Thorough knowledge of regulatory requirements.
* Thorough understanding of the drug development process.
* Advanced Clinical Monitoring experience.
* Minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
* Advanced study site management skills.
* Ability to work with minimal supervision.
* Good planning and organization skills.
* Works efficiently and effectively in a matrix environment.
* Experience in Serious Adverse Event (SAE) reporting and processing of related reports.
Travel Requirement
Willingness to travel up to 40% with overnight stay away from home.
EEO Statement
Learn more about our EEO & Accommodations request.
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