Clinical Research Associate – Cardiovascular, Vaccine, Infectious Disease

This is a fully remote position, open to applicants in California, +6 more states.

📋 Description

• Ensure adherence to performance and compliance for designated clinical research protocols and sites.

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

• Build and sustain robust relationships with site personnel.

• Execute clinical study site management and monitoring in accordance with ICH-GCP, SOPs, laws, regulations, protocols, and monitoring plans.

• Coordinate activities with sponsor roles to guarantee site readiness.

• Engage in site selection and validation processes.

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

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

• Generate precise visit and non-visit contact reports.

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

• Liaise with investigators and site staff concerning protocol execution, 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 functions, vendors, IRBs/IECs, and regulatory bodies.

• Maintain information and documentation within CTMS, eTMF, and other systems.

• Contribute as a process subject matter expert, mentor, and best-practice advocate.

• Support or lead audit and inspection initiatives.

• Conduct co-monitoring visits when necessary.

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

• Travel domestically and internationally approximately 65%-75% of the time, roughly 2-3 days per week.

⛳️ Requirements

• Must reside in Illinois, Colorado, South Florida, New York, California, Houston, or Dallas.

• Associate’s degree, certificate, or equivalent in a scientific or healthcare field plus a minimum of 5 years of relevant healthcare experience, which includes at least 2 years of direct site management or monitoring experience in a bio/pharma/CRO; or a bachelor’s degree or higher with at least 2 years of direct site management or monitoring experience in a bio/pharma/CRO.

• A current driver’s license is required.

• Approximately 65%-75% domestic and international travel; expected travel is around 2-3 days per week.

• Fluent in local languages and English, both spoken and written.

• Working knowledge of clinical research, phases of clinical trials, current GCP/ICH guidelines, and country-specific clinical research regulations.

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

• Practical understanding of Good Documentation Practices.

• Proven site management capabilities, including site performance and patient recruitment.

• Demonstrated high-level monitoring skills with independent professional judgment.

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

• Ability to comprehend and analyze data and metrics, acting accordingly.

• Competence in managing complex issues, conducting root cause analyses, and implementing preventive and corrective measures.

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

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

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

• Effectiveness in a matrix multicultural environment, establishing culturally sensitive working relationships.

• Customer-oriented, quality-focused, and compliance-driven mindset.

• Positive, growth-oriented, self-motivated, and professional demeanor.

• Required knowledge of adverse event reporting systems, clinical research methodologies, clinical site management, clinical study oversight, clinical trial planning and monitoring, data analysis and reporting, early clinical development, policy formulation, preventive action, protocol compliance, regulatory adherence, and site management.

🏝️ Benefits

• Annual bonus eligibility.

• Long-term incentive eligibility, if applicable.

• Medical healthcare benefits.

• Dental healthcare benefits.

• Vision healthcare benefits.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation time.

• Compassionate leave.

• Sick leave.

• Remote work arrangement.