FSP - Clinical Research Associate 2 - CRA 2 / Sr. CRA 1- Northeast or Central - Oncology

Auto Import

<strong>Job Description<br><br></strong><strong>Our FSP team is currently seeking Unblinded CRAs with 1-3 years of monitoring! Candidates must resided within the United States. 8-10 days on site per month being a mix of onsite and remote. Open to West coast, Central and East Coast major hub locations. <br><br></strong><strong>What You Will Do<br><br></strong>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.<br><br><strong>Responsibilities<br><br></strong><ul><li>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 -</li><li>Responsible for all aspects of site management as prescribed in the project plans</li><li>General On-Site Monitoring</li><li>Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</li><li>Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</li><li>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</li><li>Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested</li><li>Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs</li><li>Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management</li><li>Assist with training of new employees, eg. co-monitoring</li><li>Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned</li><li>Perform other duties as assigned by management<br><br></li></ul><strong>Requirements<br><br></strong><ul><li>University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)</li><li>1+ years of Clinical Monitoring experience</li><li>50-60% overnight travel<br><br></li></ul>The important thing for us is you are comfortable working in an environment that is:<br><br><ul><li>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.</li><li>Changing priorities constantly asking you to prioritize and adapt on the spot.</li><li>Teamwork and people skills are essential for the study to run smoothly.</li><li>Technology based. We collect our data directly into an electronic environment.<br><br></li></ul><strong>Work Environment<br><br></strong><ul><li>Work is performed in an office environment with exposure to electrical office equipment.</li><li>Frequent travel to clients/ site locations with occasional travel both domestic and international.<br><br></li></ul><strong>Physical Requirements<br><br></strong><ul><li>Ability to sit for extended periods and operate a vehicle safely.</li><li>Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.</li><li>Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</li><li>Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</li><li>Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</li><li>Regular and consistent attendance.</li><li>Varied hours may be required.</li><li>Target Pay Range: $100-115K based on job title<br><br></li></ul> - Remote<br><br>Applications will be accepted on an ongoing basis.<br><br>Learn more about our EEO & Accommodations request here.

Back to blog