Clinical Research Associate II

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

📋 Description

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

• Assist with the preparation and evaluation of essential documents, including informed consent forms (ICFs) and study manuals.

• Conduct site qualification, site initiation, interim monitoring, and close-out visits.

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

• Execute routine site communications, including resolving site-related issues and providing necessary protocol training.

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

• Mentor and support junior CRAs and those newly onboarded.

• Review study documents such as the Clinical Monitoring Plan and Investigator Site File documents.

• Participate in trial risk management meetings and associated procedures.

• Monitor and evaluate clinical data to ensure its accuracy, completeness, and timeliness.

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

• Assist in preparing regulatory submissions and support inspections or audits as required.

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

• Provide consistent updates to internal teams and management concerning study progress, issues, and resolutions.

⛳️ Requirements

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

• A minimum of 2 years of experience in oncology (or equivalent experience).

• Proficient in understanding clinical trial protocols, Good Clinical Practice (GCP), regulatory requirements, EDC, EMR, eTMF, and CTMS.

• Strong organizational capabilities with attention to detail and the ability to effectively prioritize tasks.

• Capacity to efficiently perform source data verification (SDV), whether remotely or onsite.

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

• Excellent written and verbal communication skills, along with strong interpersonal abilities.

• Willingness to travel domestically and internationally as required.

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

• Experience managing complex protocols and sites.

🏝️ Benefits

• Perspective Therapeutics ensures equal employment opportunities for all employees and job applicants.

• The company prohibits discrimination and harassment of any kind, regardless of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.