Sr. CRA 2, Oncology, FSP - Midwest

Job Description

Our FSP team is currently seeking an Oncology Sr. CRA 2 with 5+ years of monitoring residing in the Midwest (IL,IN,IA,KS,MI,MN,MO,ND,SD,WI, OH) area.

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)

•

5+ years of Clinical Monitoring experience

•

Oncology experience, early phase preferred

•

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: $125 - $140K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here .