This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee all clinical operational and quality elements of assigned studies, ranging from moderate to high complexity, ensuring compliance with ICH GCP guidelines.

• Create clinical tools (such as Monitoring Plans and Monitoring Guidelines) in collaboration with the Data Quality Plan.

• Guarantee the prompt establishment, organization, content, and quality of the pertinent sections of the Trial Master File (both local and central).

• Work alongside the project manager to prepare, organize, and deliver presentations at client meetings, including bid defense and hand-off sessions.

• Ensure the successful completion of the final clinical deliverable within the specified contractual timeline by preparing and tracking clinical activity timelines and metrics.

⛳️ Requirements

• Bachelor's degree or an equivalent formal academic/vocational qualification.

• Over 5 years of pertinent experience in clinical research, encompassing clinical trial operations, study management, clinical monitoring, or associated clinical research activities.

• Applicable experience in healthcare, nursing, medicine, or related fields.