FSP Clinical Research Associate II

About the position This position is fully remote, but we are looking for someone in the Midwest for a sponsor dedicated CRA position. Precision for Medicine is not your typical CRO. We are passionate about supporting professional growth and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a midsized CRO allows you to have influence and impact when it matters most with support from direct line management. To support continued growth from our clients, we are hiring all levels of CRAs experienced in monitoring Oncology or Cardiology. About you: You are calm, thoughtful, and responsive when things don’t go as planned. You are well-prepared, whether it be for an investigator meeting, site visit, or project team update, you are always staying two steps ahead of the game. You find quick and creative ways of overcoming difficulties. You have an impeccable eye for detail. You identify potential study risks and propose solutions on how to mitigate them. You take responsibility in the quality and outcomes of your work. You are adept at handling conflict by using tried and true resolution strategies. You have experience in study start up activities. How you will spend your days as a CRA You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.). As a CRA, you will work with 2-3 protocols on average and support Project Managers with trials that are larger in scope. You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations. About Precision for Medicine Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offerings enable the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for complex disease states. Precision medicine is revolutionizing the attack on cancer. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway. We invite you to learn more about our growing organization serving clients that are researching groundbreaking therapies. We strive to ensure employees feel appreciated through a multitude of benefits including paid time off, volunteer time off, robust medical offerings, non-vested 401k plus company match, paid parental leave and more. At Precision, your ideas and contributions are valued and nurtured, impacting positive change for the company.

Responsibilities

• Monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
• Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
• Work with 2-3 protocols on average and support Project Managers with trials that are larger in scope.
• Interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.

Requirements

• 4-year college degree or equivalent experience
• 2+ years CRA experience within the CRO to be considered for a CRA II.
• Experience in monitoring cardiology or Lupus
• Availability for domestic travel including overnight stays, up to approximately 50-60% travel commitment (potential international travel may be required for some senior level positions)
• Fluency in English and for non-English speaking countries the local language of country where position based

Benefits

• paid time off
• volunteer time off
• robust medical offerings
• non-vested 401k plus company match
• paid parental leave

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