Sr Clinical Research Associate I, Phase I

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 - $130K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.