Job Description
Our Phase I team is currently seeking a Senior Clinical Research Associate with 3+ years of experience. Ideal candidates would have phase I experience and reside in 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
Requirements
* University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
* 3+ years of Clinical Monitoring experience
* Phase I experience
* 40-50% 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 - $135K
#LI - Remote
Applications will be accepted on an ongoing basis.
Learn more about our EEO & Accommodations request here.
Job Tags
Work at office, Local area, Remote work, Night shift