FSP Clinical Research Associate 2 - Southeast - Non Oncology

Fortrea; Nashville (TN); À distance; USD 100 000 - 112 000; Plein temps

Résumé du poste

Fortrea is seeking a Clinical Monitor to oversee study site monitoring, data integrity, and SAE reporting across trials. You will ensure proper consent, regulatory compliance, and close collaboration with vendors and site staff in a fast-paced environment.

The role requires a university degree or allied health certification, plus approximately two years of clinical monitoring experience and up to 60% overnight travel.

Qualifications

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure).
• 2 years of Clinical Monitoring experience.
• 60% overnight travel.

Responsabilités

• Monitor and manage study site visits, routine monitoring, and site close-out.
• Ensure informed consent and protocol compliance; liaise with vendors.
• Oversee data quality, CRFs, and SAE reporting.
• Support training of new staff and coordinate local projects as needed.

Connaissances

Clinical monitoring

Formation

Bachelor's degree or allied health certification

Description du poste

WHAT YOU WILL DO

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.

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 plansGeneral On-Site MonitoringEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure 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 dataResponsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requestedComplete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by managementAssist with training of new employees, eg. co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assignedPerform other duties as assigned by management

Requirements

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) 2 years of Clinical Monitoring experience 60% overnight travel

The important thing for us is you are comfortable working in an environment that is: Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. Changing priorities constantly asking you to prioritize and adapt on the spot. Teamwork and people skills are essential for the study to run smoothly. Technology based. We collect our data directly into an electronic environment.

Work Environment: Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements: Ability to sit for extended periods and operate a vehicle safely. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Target Pay Range: $100-112K

#LI - RemoteApplications will be accepted on an ongoing basis.

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