Clinical Research Associate, Oncology

This is a fully remote position, open to applicants in California, +4 more states.

📋 Description

• Oversee performance and compliance for designated clinical research protocols and sites.

• Ensure that study execution adheres to ICH/GCP, local regulations, company policies, procedures, quality benchmarks, and adverse event reporting obligations.

• Serve as the primary contact and site manager throughout all stages of clinical research studies.

• Foster and maintain robust relationships with sites.

• Engage in clinical study site management and monitoring tasks.

• Attain a deep understanding of study protocols and associated procedures.

• Coordinate activities with sponsor roles to ensure Site Readiness.

• Take part in site selection and validation processes.

• Conduct both remote and on-site monitoring and oversight activities.

• Execute validation, initiation, monitoring, and close-out visits.

• Draft clear, comprehensive, and precise visit and non-visit contact reports.

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

• Liaise with investigators and site personnel on protocol execution, recruitment, retention, deviations, regulatory 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 functions, vendors, IRBs/IECs, and regulatory bodies.

• Maintain information and documentation in CTMS, eTMF, and other relevant systems.

• Act as a subject matter expert, mentor, and best-practice promoter.

• Assist or lead audit and inspection undertakings.

• Conduct co-monitoring visits as deemed appropriate.

• Identify potential new sites and enhance their clinical research capabilities.

⛳️ Requirements

• Must reside in New York, New Jersey, Texas, Chicago, Southern California, or Missouri.

• Associate's degree, certificate, or equivalent in a scientific/healthcare field, along with at least 5 years of pertinent healthcare experience, including a minimum of 2 years in direct site management/monitoring in 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.

• Exceptional communication skills, encompassing understanding and presenting technical information.

• Familiarity with clinical research and the phases of clinical trials.

• Knowledge of current GCP/ICH and country-specific clinical research regulations and guidelines.

• Awareness of global and regional clinical research guidelines.

• Practical knowledge of Good Documentation Practices.

• Proven abilities in site management, including site performance and patient recruitment oversight.

• Demonstrated advanced monitoring skills with independent professional judgment.

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

• Ability to adapt to new IT applications.

• Capability to comprehend and analyze data/metrics and take appropriate actions.

• Proficient in managing complex issues, performing root cause analysis, and executing preventive and corrective measures.

• Strong time management, organizational, interpersonal, conflict resolution, and problem-solving skills.

• Ability to work independently across multiple protocols, sites, and therapeutic areas.

• Capacity to prioritize and manage multiple tasks in a dynamic environment.

• Effective in a matrix multicultural environment while maintaining culturally sensitive working relationships.

• Commitment to customer focus and quality/compliance.

• Positive, growth-oriented, self-motivated attitude.

• A valid driver's license is required.

• Willingness to travel domestically and internationally approximately 65%-75% of working time, around 2-3 days per week.

• No visa sponsorship available.

🏝️ Benefits

• Eligibility for annual bonuses.

• Long-term incentive eligibility, if applicable.

• Medical healthcare coverage.

• Dental healthcare coverage.

• Vision healthcare coverage.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation days.

• Compassionate leave days.

• Sick leave.

• Flexible work arrangements, including remote options.