Clinical Research Associate – Oncology, Monitoring Experience Required

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

📋 Description

• Execute site monitoring responsibilities for oncology clinical trials.

• Provide oversight, leadership, and direction in the management and execution of clinical trials.

• Ensure compliance with protocols, maintain quality, and adhere to SOPs, timelines, and budgets.

• Review monitoring visit reports and perform co-monitoring and evaluation visits.

• Guarantee timely investigator site visits.

• Coordinate cross-functional solutions for clinical trial monitoring issues.

• Assist with the development of study-specific Monitoring Plans and training presentations.

• Support ethics document collection and site contract negotiations.

• Provide monthly billing details to the Finance department.

• Manage study budgets and serve as the sponsor referent for stand-alone projects.

• Conduct qualification, initiation, interim, and close-out visits, both remotely and on-site.

• Prepare precise monitoring visit reports that address site issues, resolutions, protocol deviations, study progress, and enrollment.

• Verify source documents to ensure CRF data integrity.

• Conduct quality control and verification of eTMF/TMF documents.

• Oversee investigational product accountability.

• Review site regulatory binders.

• Serve as the primary contact for protocol/GCP compliance, accrual assessment, and sponsor inquiries.

• Ensure adherence to ICH GCP, FDA regulations, and company/sponsor SOPs.

• Participate in internal, client/sponsor, scientific, and other meetings.

• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs.

• Address discrepant data queries in collaboration with in-house CRAs/CTC and Data Management.

• Identify site issues and devise problem-solving strategies.

• Prepare for audits at study sites.

• Work with other CRAs to ensure consistent practices.

• Assist in the training and onboarding of new CRAs.

• Mentor CRAs.

• Collaborate on the development and maintenance of CTMS.

• Manage conflicting priorities and meet commitments.

• Perform additional assigned responsibilities.

⛳️ Requirements

• Minimum of 2 years of oncology monitoring experience is required.

• Capability to build and maintain positive relationships with Sponsors, Site, and Project Team members.

• Ability to independently manage monitoring activities.

• Quality-focused; demonstrated ability to be meticulous, thorough, and detail-oriented.

• Strong organizational skills with the ability to multitask in a fast-paced environment.

• Ability to prioritize tasks, manage time effectively, and resolve problems.

• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills.

• Willingness to travel.

• Capacity to manage stress effectively.

• Professional, trustworthy, and disciplined demeanor.

• Ability to solve unstructured or ambiguous challenges.

• Proficient command of the local language, both written and verbal, in the country where monitoring activities occur.

• Excellent communication and interpersonal skills with a focus on customer service.

• Competent computer skills, including experience with clinical trial management systems, clinical trial databases, and electronic data capture.

• Familiarity with clinical research, ICH GCP, and local regulations.

• Understanding of regulatory and ethical requirements.

• Bachelor's degree in Biology, Life Sciences, or a related field equivalent to a BS education.

• Proficiency in the English language.

🏝️ Benefits

• Comprehensive health insurance plans.

• Competitive salary with performance bonuses.

• Opportunities for professional development and training.

• Flexible working hours and remote work options.

• Supportive and collaborative work environment.