Clinical Research Associate

$80,000 - $125,000/Yr

Novotech International Gmbh - Charleston, SC

Full-time - Mid Level

Charleston, SC

1,001-5,000 employees

Miscellaneous Manufacturing

About the position

The Clinical Research Associate (CRA) plays a crucial role in ensuring the rights and wellbeing of trial participants while maintaining the integrity of trial data. The CRA serves as the primary liaison between Investigational Sites, Novotech, and Sponsors, ensuring compliance with ICH GCP guidelines and regulatory requirements. This position focuses on building strong relationships with site personnel and managing clinical trials effectively.

Responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel to manage clinical trials efficiently.
• Foster internal and external customer relationships to ensure timely and productive project delivery.
• Collaborate with the In-house Clinical Research Associate and Regulatory Start-Up Associate to prepare site essential documents and support ethics and regulatory submissions.
• Understand local and international regulatory requirements relevant to specific clinical trials in collaboration with the Regulatory Start-up Team.
• Drive site recruitment and engagement initiatives, preparing and updating site-specific recruitment plans as needed.
• Monitor investigational sites according to ICH GCP and the Clinical Monitoring Plan, conducting various monitoring visit types.
• Ensure the rights and wellbeing of trial participants are protected, including consent checks and protocol compliance.
• Verify the accuracy and completeness of trial data, resolving queries as per study timelines.
• Ensure proper storage, dispensing, accounting, and reconciliation of study drugs.

Requirements

• Graduate in a clinical or life sciences-related field; relevant experience in allied professions may be considered.
• Good time management skills and attention to detail.
• Ability to work well in a team and be computer literate.
• At least 2-3 years of Clinical Research Associate experience in the clinical industry is preferred.
• Excellent interpersonal and team skills with a commitment to developing innovative treatments.

Nice-to-haves

• Experience in the research or pharmaceutical industry is preferred.

Benefits

• Flexible working options
• Paid parental leave for both parents
• Flexible leave entitlements
• Wellness programs
• Ongoing development programs