Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Fortrea Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

General On-Site Monitoring Responsibilities:

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.

Prepare accurate and timely trip reports.

Manage small projects under direction of a Project Manager/Director as assigned.

Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.

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

Organize and make presentations at Investigator Meetings.

Report, write narratives and follow-up on serious adverse experiences.

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 - 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.

Complete process of 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.

Co-ordinate 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


Job requirements:

Bachelor degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

At least 1 year CRA experience. Full experience of SSV-SIV-SMV-COV is preferred. SSU stage experience is a MUST.

Oncology study experience is highly preferred.

Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.

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

English workable is a MUST.