Clinical Research Associate II

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Engage in feasibility studies and participate in the site selection process.

• Aid in the drafting and evaluation of key documents such as informed consent forms (ICFs) and study manuals.

• Conduct site qualifications, initiation, interim monitoring, and close-out visits to ensure adherence to study protocols, Good Clinical Practice (GCP), and regulatory standards.

• Regularly assess Investigator Site Files (ISF) to help maintain site audit readiness.

• Facilitate routine communication with sites, addressing issues and delivering necessary protocol training.

• Contribute to the creation and presentation of training materials for Clinical Research Associates (CRAs).

• Mentor and provide assistance to junior CRAs and those who have recently joined the team.

• Review study-related documents, including the Clinical Monitoring Plan and Investigator Site File documentation.

• Participate in trial risk management discussions and processes.

• Identify, develop, and execute process improvement initiatives to enhance monitoring quality and reduce trial risks.

• Monitor and evaluate clinical data to ensure it is accurate, complete, and timely.

• Collaborate closely with data management teams to address data discrepancies and maintain data integrity throughout the trial.

• Assist in the preparation of regulatory submissions and provide support during inspections and audits as required.

• Ensure all clinical trial activities comply with relevant regulatory requirements and internal protocols.

• Cultivate strong relationships with investigators, study coordinators, and other essential stakeholders.

• Provide consistent updates to internal teams and management regarding study progress, challenges, and resolutions.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field; an advanced degree (e.g., Master’s, PhD) is preferred.

• At least 2 years of experience in oncology (or equivalent experience).

• Proficient in understanding clinical trial protocols, GCP, regulatory requirements, EDC, EMR, eTMF, and CTMS.

• Strong organizational skills with a keen eye for detail and the ability to prioritize tasks effectively.

• Capable of conducting source data verification (SDV) efficiently whether remotely or onsite.

• Ability to identify protocol deviations and effectively determine root causes, assisting sites in implementing corrective or preventative measures.

• Excellent written and verbal communication skills.

• Willingness to travel domestically and internationally as needed.

• Typical CRA travel is up to 50%, but may increase to 75% for specific project deliverables (e.g., database lock, etc.).

• Competent to perform the CRA role with minimal onboarding or training.

• Capable of managing complex protocols and sites.

🏝️ Benefits

• Perspective Therapeutics offers equal employment opportunities and strictly prohibits discrimination and harassment of any kind.

• Reasonable accommodations may be provided to enable individuals with disabilities to perform essential functions.