Senior Clinical Research Associate - Southeast Region (Remote)

About the position

The role is responsible for ensuring performance and compliance for assigned clinical research protocols and sites within a country. The individual acts as the primary site contact and manager throughout all phases of a clinical research study, ensuring adherence to ICH/GCP guidelines, company policies, and quality standards. The position involves developing new clinical research sites, managing site relationships, and participating in various monitoring and oversight activities.

Responsibilities

• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Coordinate & manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participate & provide inputs on site selection and validation activities.
• Perform remote and on-site monitoring & oversight activities to ensure data accuracy and subject safety.
• Conduct site visits including validation, initiation, monitoring, and close-out visits, and record comprehensive visit reports.
• Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
• Communicate with Investigators and site staff on protocol conduct, recruitment, retention, and overall site performance.
• Identify, assess, and resolve site performance, quality, or compliance problems and escalate as needed.
• Work in partnership with internal and external stakeholders to support assigned sites.
• Manage and maintain information in CTMS, eTMF, and other systems as appropriate.
• Act as a Subject Matter Expert (SME) for monitoring processes and systems, sharing best practices and providing training.
• Support and/or lead audit/inspection activities as needed.
• Contribute to the identification of new potential sites and develop strong clinical research capabilities.
• Mentor junior CRAs on process/study requirements and perform co-monitoring visits.

Requirements

• Minimum 4 years of direct site management (monitoring) experience in a bio/pharma/CR environment.
• Fluent in local languages and English (verbal and written) with excellent communication skills.
• Excellent understanding of clinical research, phases of clinical trials, and current GCP/ICH & country clinical research laws and guidelines.
• Demonstrated ability to mentor and lead others.
• Hands-on knowledge of Good Documentation Practices.
• Proven skills in site management, including independent management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills, including use of MS Office and various clinical IT applications.

Nice-to-haves

• B.A./B.S. with strong emphasis in science and/or biology.

Benefits

• Flexible work arrangements including remote work options.
• Employee assistance programs for mental health support.
• Professional development opportunities and training programs.