Clinical Research Associate II - North Carolina, East Coast

Perspective Therapeutics•,

1d•Remote

About The Position

As a Clinical Research Associate II (CRA II) specializing in oncology, you will play a crucial role in the execution and management of Phase 1, Phase 2, and Phase 3 clinical trials. You will collaborate closely with cross-functional teams to ensure adherence to protocols, regulatory requirements, and high-quality standards throughout the clinical trial process. Qualified Candidates need to live in or near North Carolina.

Requirements

Bachelor’s degree in life sciences or a related field
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
Grows to lead other CRAs

Nice To Haves

advanced degree (e.g., Master’s, PhD) preferred

Responsibilities

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