Clinical Research Associate (Remote)

Placements24; United States; A distancia; USD 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary and bonuses

Medical, dental, and vision coverage

Retirement savings plan

Generous leave and holidays

Home office equipment allowance

Flexible work schedule

Descripción de la vacante

Placements24 is seeking a dedicated Clinical Research Associate for a fully remote role. You will monitor clinical trial sites, verify data integrity, and ensure regulatory compliance across multiple studies from a distributed team.

The ideal candidate holds a life science degree with at least 3 years of CRA experience, strong knowledge of GCP/ICH, and proficiency in EDC/CTMS. This remote-first role offers flexibility and opportunities for professional development.

Formación

• Bachelor's degree in life science, nursing, or related discipline.
• Minimum of 3 years of direct CRA experience.
• Knowledge of GCP, ICH guidelines, and regulatory requirements.
• Experience managing multiple trials and sites.
• Proficiency with EDC, CTMS and related software.

Responsabilidades

• Conduct site visits (initiation, monitoring, close-out) via remote tools.
• Verify data accuracy and compliance using source documents and EDC.
• Ensure adherence to GCP, SOPs and study protocols.
• Serve as primary contact for assigned sites.
• Manage site recruitment and enrollment with investigators.
• Prepare study documents for regulators and IRBs/ECs.
• Monitor subject safety and report AEs/SAEs.
• Oversee study drug accountability at sites.
• Communicate with project teams (managers, data managers, investigators).

Conocimientos

Organizational skills

Analytical abilities

Problem-solving

Communication skills

Interpersonal skills

Remote collaboration

Educación

Bachelor's degree in life science or related field

Herramientas

EDC systems

CTMS

Clinical research software

Descripción del empleo

About the Role

Our client is a renowned pharmaceutical company seeking a dedicated Clinical Research Associate (CRA) to join their expanding team. This position is a fully remote opportunity, allowing you to contribute significantly to our clinical trial operations without the need for physical office presence. You will play a crucial role in ensuring the smooth execution of clinical studies by monitoring trial sites, verifying data integrity, and upholding regulatory compliance. This role is essential for bringing life‑saving therapies to patients and offers a chance to be part of a dedicated, distributed team committed to excellence. We champion a remote‑first culture, empowering our employees with flexibility while maintaining the highest standards of professional conduct and scientific integrity. Your expertise will be vital in managing multiple studies and ensuring they meet all ethical and regulatory requirements, making a tangible difference in the advancement of healthcare. Join us in our mission to improve patient lives through rigorous clinical research conducted by a talented, globally dispersed team.

Key Responsibilities

• Conduct site visits (initiation, monitoring, close‑out) according to protocol and regulatory requirements, primarily remotely through virtual tools.
• Verify the accuracy, completeness, and compliance of clinical trial data by reviewing source documents and electronic data capture (EDC) systems.
• Ensure adherence to Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and study protocols.
• Serve as the primary point of contact for assigned clinical trial sites, addressing questions and resolving issues promptly.
• Manage study site recruitment and enrollment activities, working closely with investigators and site staff.
• Prepare and submit essential study documents to the appropriate regulatory authorities and Institutional Review Boards (IRBs)/Ethics Committees.
• Monitor subject safety and report adverse events (AEs) and serious adverse events (SAEs) according to protocol and regulatory standards.
• Oversee study drug accountability and management at clinical sites.
• Communicate effectively with internal project teams, including study managers, data managers, and investigators.

Requirements

• Bachelor's degree in a life science, nursing, or related discipline.
• Minimum of 3 years of direct experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Proof of proven ability to manage multiple clinical trials and sites simultaneously.
• Excellent organizational, analytical, and problem‑solving skills.
• Proficiency in using EDC systems, CTMS (Clinical Trial Management Systems), and other clinical research software.
• Strong interpersonal and communication skills, essential for remote team collaboration and site interactions.
• Ability to work independently and proactively in a remote setting.
• Willingness to travel occasionally for essential site visits or team meetings, as needed.

Benefits

• Competitive salary and performance‑based bonuses.
• Comprehensive medical, dental, and vision coverage.
• Retirement savings plan.
• Generous annual leave and public holiday entitlement.
• Continuous training and professional development opportunities.
• Home office equipment allowance.
• Flexible work schedule options.