CRA II, US
About The Position
The Clinical Research Associate 2 (CRA2) is part of Emerald Clinical’s Clinical Operations group, which manages clinical trial sites, monitoring activities, and operational support. The group assigns resources to projects to help implement project plans and ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs). The CRA2 supports clinical trials by coordinating site selection and start-up, conducting monitoring visits, managing regulatory and essential site documentation, and overseeing site budgets, contracts, payments, trial supplies, and trial records. The role also trains and supports investigators and site personnel, helps maintain compliance and quality, and contributes to recruitment efforts. The position requires travel and offers hybrid or remote arrangements depending on location and role.
Requirements
- Qualifications in a related science or healthcare discipline.
- Previous clinical trial experience in an academic, CRO, or pharmaceutical environment.
- Two to five experiences in on-site monitoring and site management; the posting states this experience is mandatory.
- Practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
- Competence in ethical and participant safety considerations, site start-up and conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
- Competence in negotiation and conflict resolution, critical thinking, problem-solving, decision-making, and strategic thinking.
- Solid interpersonal communication and presentation skills.
- Ability to work flexibly and effectively in a multidisciplinary team, both autonomously and with a wide range of stakeholders.
- Ability to adapt to changing organizational priorities and ambiguous environments.
- Ability and willingness to travel.
Responsibilities
- Coordinate identification, feasibility assessment, and selection of investigators and trial sites.
- Complete monitoring activities according to the Monitoring Plan and submit accurate monitoring visit reports within required timeframes.
- Prepare, plan, organize, and conduct site evaluation visits and report findings to support site selection.
- Prepare and submit regulatory packages, or liaise with regulatory specialists on regulatory packages, import/export requirements, and Ethics Committee package updates.
- Negotiate site budgets, coordinate site contract execution, track invoicing, and ensure timely site payments.
- Prepare, plan, organize, and conduct site initiation visits.
- Develop and maintain monitoring tools and project-specific documents.
- Motivate and train investigators and site personnel on the protocol, investigational product, and trial requirements.
- Collect, review, and approve essential documents from trial sites, ensuring quality and compliance, and code documents for Trial Master File (TMF) filing.
- Reconcile the contents of the in-house TMF and site Investigator Site Files.
- Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies according to site and trial requirements.
- Maintain trial information in the clinical trial management system and other trial tracking and reporting tools.
- Support strategies to increase recruitment.
Benefits
- Competitive salary and benefits package tailored to skills and experience.
- Hybrid or remote working arrangements, depending on location and role.
- Learning opportunities and access to a global network of scientific leaders for career development.
- Employee wellbeing programs and initiatives supporting work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
- Exposure to diverse projects and clients through the company’s international reach.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
