Sr. Clinical Research Associate I - Unblinded

Fortrea•Durham, NC

3d•Remote

About The Position

Our FSP team is currently seeking a Unblinded Sr. CRA 1 with 3+ years of monitoring! Candidates must resided within the United States. You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Requirements

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
4+ years of Clinical Monitoring experience
50-60% overnight travel
Comfortable working in a fast-paced environment where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
Comfortable with changing priorities constantly asking you to prioritize and adapt on the spot.
Teamwork and people skills are essential for the study to run smoothly.
Comfortable working in a technology-based environment where data is collected directly into an electronic environment.

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
Monitor data for missing or implausible data
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Complete Serious Adverse Event (SAE) reporting, process production of repo11s, 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 of new employees, eg. 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