Clinical Research Associate II/Senior – Oncology

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

📋 Description

• Oversee and coordinate all elements of clinical monitoring and site management.

• Perform both remote and onsite monitoring visits to evaluate regulatory compliance and manage necessary documentation.

• Ensure that trials adhere to approved protocols, ICH GCP guidelines, relevant regulations, and SOPs.

• Maintain audit readiness and foster collaborative relationships with investigator sites.

• Monitor investigator sites utilizing a risk-based monitoring approach.

• Utilize root cause analysis, critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive measures.

• Ensure data integrity through source document review, source data verification, and case report form evaluation.

• Evaluate investigational products via physical inventory and records assessment.

• Document findings in reports and letters, escalating any deficiencies to clinical management.

• Maintain communication with investigative sites between monitoring visits and ensure issues are resolved.

• Carry out monitoring activities as outlined in approved monitoring plans.

• Engage in investigator payment processes and share responsibilities for resolving issues.

• Track trial progress and provide updates to the Clinical Team Manager.

• Update clinical study systems, including CTMS, and conduct quality-control checks of CTMS reports.

• Participate in investigator meetings and identify potential investigators for client companies.

• Initiate clinical trial sites and make recommendations regarding site compliance.

• Ensure trial closeout and retrieval of trial materials.

• Verify that essential documents are complete and conduct onsite file reviews.

• Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls.

• Facilitate communication among investigative sites, client companies, and the PPD project team.

• Address company, client, and regulatory requirements, audits, and inspections.

• Complete administrative tasks such as expense reports and timesheets.

• Contribute to process improvement initiatives and other project-related work.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nurse Certification, or an equivalent and relevant formal academic/vocational qualification.

• At least 1 year of oncology monitoring experience, or a minimum of 2 years of standard monitoring experience with relevant prior clinical experience (e.g., MD, RN, Study Coordinator).

• Strong clinical monitoring skills.

• Understanding of medical/therapeutic area knowledge and medical terminology.

• Proven application of ICH GCPs, applicable regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving abilities.

• Capability to manage Risk-Based Monitoring concepts and processes.

• Effective oral and written communication skills when interacting with medical personnel.

• Customer-focused with strong listening skills and attention to detail.

• Excellent interpersonal, organizational, and time management skills.

• Adaptability and flexibility.

• Ability to work independently or collaboratively in a team environment.

• Proficient in Microsoft Office and capable of learning necessary software.

• Strong English language and grammar skills.

• Good presentation skills.

• Willingness to comply with specific sponsor/client/site requirements, including disclosure of vaccination status or other personal information.

• Availability and willingness to travel frequently, typically 60–80%, including frequent drives to site locations and potential extended overnight stays.

• Capability to work in office, laboratory, clinical, and/or home office settings.

• Ability to utilize required personal protective equipment, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.