Clinical Research Associate – Oncology

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

📋 Description

• Ensure performance and compliance for designated protocols and sites within the country.

• Guarantee adherence to study conduct in accordance with ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting obligations.

• Serve as the primary contact and manager for sites throughout all phases of clinical research studies.

• Expand and develop the clinical research territory by identifying and nurturing new sites.

• Contribute as a subject matter expert for monitoring processes and systems during internal meetings and workstreams.

• Cultivate strong relationships with sites to ensure seamless continuity across all trial phases.

• Conduct clinical study site management and monitoring in compliance with ICH-GCP, SOPs, local laws, regulations, protocols, and monitoring plans.

• Coordinate tasks with sponsor roles to ensure site readiness.

• Engage in site selection and validation processes.

• Execute remote and on-site monitoring and oversight tasks.

• Carry out validation, initiation, monitoring, and close-out visits; document findings in visit and non-visit contact reports.

• Gather, review, and oversee regulatory documentation for study initiation, maintenance, and closure.

• Communicate with investigators and site personnel about protocol adherence, recruitment, retention, deviations, documentation, audits/inspections, and site performance.

• Identify, evaluate, resolve, and escalate issues related to site performance, quality, and compliance.

• Collaborate with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters teams, vendors, IRBs/IECs, and regulatory authorities.

• Manage and maintain information and documentation within CTMS, eTMF, and other relevant systems.

• Act as a process subject matter expert, mentor, and contributor of best practices.

• Assist and/or lead audit and inspection processes.

• Conduct co-monitoring visits.

• Identify potential new sites and aid in enhancing their clinical research capabilities.

⛳️ Requirements

• Associate's degree, certificate, or equivalent in a scientific/healthcare discipline along with at least 5 years of related healthcare experience, including a minimum of 2 years in direct site management (monitoring) within a bio/pharma/CRO; OR a bachelor's degree (or higher) with at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

• Proficient in local languages and English, both verbal and written.

• Solid understanding and practical knowledge of clinical research, clinical trial phases, current GCP/ICH standards, and local clinical research laws and guidelines.

• Familiarity with global and country/regional clinical research guidelines.

• Practical experience with Good Documentation Practices.

• Demonstrated site management proficiency, including site performance and patient recruitment.

• Proven high-level monitoring capabilities with independent professional judgment.

• Strong IT skills, including proficiency in MS Office and clinical IT applications on computers, tablets, and mobile devices.

• Ability to comprehend and analyze data/metrics.

• Capable of managing complex issues and conducting root cause analysis.

• Effective skills in time management, organization, interpersonal relations, conflict resolution, problem-solving, and prioritization.

• Ability to work independently across various protocols, sites, and therapy areas.

• Skillful in working effectively within a matrix multicultural environment.

• Dedication to customer focus and quality/compliance.

• Expected travel of approximately 65%-75%, both domestically and internationally; anticipated travel of about 2-3 days per week.

• Current driver's license preferred.

• No visa sponsorship available.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical, dental, and vision healthcare.

• Additional insurance benefits for employees and families.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation time.

• Compassionate and sick leave.

• Remote work arrangement.