Senior Clinical Research Associate (Contractor)

Emerald Clinical Trials • North Carolina, NC

5d • $100

About The Position

The Senior Clinical Research Associate is a member of Emerald Clinical’s Clinical Operations group, which manages sites, performs monitoring, and provides operational support for clinical trials. The group assigns resources to projects to help implement project plans and ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs).

The role coordinates trial site selection, start-up, and management; conducts monitoring activities and visits; supports regulatory submissions and site contracts; trains site personnel; maintains trial documentation and tracking systems; manages investigational product and trial supplies; and supports recruitment efforts. The position requires clinical-trial monitoring and site-management experience, knowledge of ICH-GCP and applicable ethical and regulatory requirements, and willingness to travel. The role is offered as a contractor.

Requirements

• Qualifications in a related science or health care discipline.
• Previous clinical-trial experience in an academic, CRO, or pharmaceutical environment.
• 2–5 experiences in on-site monitoring and site management experience are mandatory, as stated in the posting.
• 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 within 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 prepare accurate monitoring visit reports within established 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 specialist colleagues on their preparation, importation and exportation 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 to ensure quality and compliance, and code documents for Trial Master File filing.
• Reconcile the in-house Trial Master File with 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 boost recruitment efforts.

Benefits

• Competitive compensation with a tailored salary and benefits package.
• Hybrid or remote working arrangements, depending on location and role.
• Learning opportunities and access to a global network of scientific leaders to support career growth.
• 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.

What This Job Offers

• Career Level: Senior
• Education Level: No Education Listed