Clinical Research Associate, Cardiovascular

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

📋 Description

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

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

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

• Enhance and grow the clinical research territory by identifying and cultivating new sites.

• Engage in internal meetings and workstreams as a subject matter expert on monitoring processes.

• Establish and maintain strong relationships with sites to ensure continuity throughout all phases of trials.

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

• Coordinate and oversee tasks with sponsor roles to ensure site readiness.

• Provide insights on site selection and validation processes.

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

• Carry out validation, initiation, monitoring, and close-out visits while documenting visit and non-visit contact reports.

• Gather, review, and oversee regulatory documentation necessary for study start-up, maintenance, and close-out.

• Liaise with investigators and site staff regarding 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 authorities.

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

• Contribute as a process subject matter expert, mentor, and by sharing best practices.

• Support and/or lead audit and inspection activities.

• Conduct co-monitoring visits where necessary.

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

⛳️ Requirements

• Associate's degree, certificate, or equivalent in a scientific/healthcare discipline with a minimum of 5 years of relevant healthcare experience, including at least 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 experience in a bio/pharma/CRO.

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

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

• Good grasp of global and country/regional clinical research guidelines.

• Practical knowledge of Good Documentation Practices.

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

• Demonstrated high-level monitoring skills with the ability to make independent professional judgments.

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

• Capability to comprehend and analyze data/metrics.

• Ability to tackle complex issues and adopt a solution-oriented approach.

• Skills in root cause analysis and implementing preventive/corrective actions.

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

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

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

• Ability to work efficiently in a diverse multicultural environment while maintaining culturally sensitive working relationships.

• Current driver's license is preferred.

• Residence in Florida, Alabama, or Georgia is highly preferred.

• Willingness to travel domestically and internationally approximately 65%-75% of working hours; expected travel of 2-3 days per week.

🏝️ Benefits

• Annual bonus and long-term incentive, if applicable.

• Comprehensive medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation time.

• Compassionate and sick leave.

• Remote work arrangements available.

• No relocation required.