Clinical Research Associate II

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🌽 Illinois – Remote

🌽 Illinois – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Perspective Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2023

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $400k Grant on 2024-02

Biotechnology • Healthcare Insurance • Pharmaceuticals

Perspective Therapeutics is a biotechnology company focused on developing innovative cancer treatments through a unique class of theranostics. Their proprietary technologies enable the targeting of specific tumors for treatment while minimizing toxicity to healthy tissues. By utilizing radiation, radiopharmaceuticals, and advanced imaging technologies, they aim to improve treatment efficacy and provide better outcomes for cancer patients.

📋 Description

• Participate in study feasibility assessments, and site selection processes • Assist in the preparation and review of essential documents such as informed consent forms (ICFs) and study manuals • Conduct site qualification, site initiation, interim monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory guidelines • Regularly review Investigator Site Files (ISF) to assist in maintaining site audit readiness • Perform routine site communication, including resolving site issues and providing protocol training as necessary • Contribute to development and delivery of CRA training materials • Mentor and support junior CRAs and newly onboarded CRAs • Review study documents including the Clinical Monitoring Plan and Investigator Site File documents • Participate in trial risk management meetings and procedures • Identify, develop and implement process improvement initiatives to enhance monitoring quality and mitigate trial risks • Monitor and review clinical data to ensure accuracy, completeness, and timeliness • Work closely with data management teams to resolve data discrepancies and ensure data integrity throughout the trial • Assist in the preparation of regulatory submissions and support inspections/audits as needed • Ensure that all clinical trial activities are conducted in accordance with applicable regulatory requirements and internal procedures • Foster strong relationships with investigators, study coordinators, and other key stakeholders • Provide regular updates to internal teams and management regarding study progress, issues, and resolutions.

🎯 Requirements

• Bachelor’s degree in life sciences or a related field; advanced degree (e.g., Master’s, PhD) preferred • Minimum 2 years oncology experience (or commensurate) • Proficiency in understanding clinical trial protocols, GCP, regulatory requirements, EDC, EMR, eTMF, and CTMS • Strong organizational skills with attention to detail and the ability to prioritize tasks effectively • Ability to effectively and efficiently perform source data verification (SDV) whether remotely or onsite • Ability to identify protocol deviations and effectively identify root cause and assist sites in implementing corrective or preventative actions • Excellent communication and interpersonal skills, both written and verbal • Ability to travel domestically and internationally as required • Typical CRA travel is up to 50%, however, at times can go up to 75% for certain project deliverables (e.g. database lock, etc.) • Ability to perform the CRA role without significant onboarding or training • Can manage complex protocols/sites

🏖️ Benefits

• Perspective Therapeutics provides equal employment opportunities and prohibits discrimination and harassment of any type. • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.