Sr. Clinical Research Associate I Unblinded

Our FSP team is currently seeking a Unblinded Sr. CRA 1 with 3 years of monitoring! Candidates must resided within the United States.

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 -monitoring

• Coordinate designated clinical projects as a Local Project Coordinator (with supervision ifapplicable) 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)

• 4 years of Clinical Monitoring experience

• 50-60% 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: $125 - $132K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here .

Required Experience:

Senior IC