Clinical Research Associate II, Phase I
$105k - $118kFortrea
Our Phase I team is currently seeking a Clinical Research Associate II with 1+ years of on-site monitoring experience. Ideal candidates would have phase I experience and reside within the U.S. 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 plans
- General On-Site Monitoring
- 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
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 1+ years of Clinical Monitoring experience
- Phase I experience
- 40-50% overnight travel
- 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 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.
- 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: $105 - $118K
Vacancy posted 1 day ago
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