Sr. CRA 2, FSP - Invitro Diagnostics - West Coast

Our FSP team is currently seeking Sr. CRA 2s with 4+ years of monitoring residing on the West Coast US!
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 :

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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 -

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Responsible for all aspects of site management as prescribed in the project plans

- General On-Site Monitoring

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Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

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Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

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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

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Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested

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Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs

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Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management

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Assist with training of new employees, eg. co-monitoring

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Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned

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Perform other duties as assigned by management

Requirements

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University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)

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4+ years of Clinical Monitoring experience

- 50+% overnight travel

The important thing for us is you are comfortable working in an environment that is:

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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.

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Changing priorities constantly asking you to prioritize and adapt on the spot.

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Teamwork and people skills are essential for the study to run smoothly.

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Technology based . We collect our data directly into an electronic environment.

Work Environment:

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Work is performed in an office environment with exposure to electrical office equipment.

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Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements:

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Ability to sit for extended periods and operate a vehicle safely.

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Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

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Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

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Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

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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: $130 - $142K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.

Originally posted on Himalayas