CRO – Clinical Trials Assistant

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support to Clinical Operations to ensure that studies are conducted on schedule, within budget, and adhere to SOPs, FDA regulations, and ICH/GCP guidelines.

• Organize and archive clinical trial master file documents, including those from clinical study sites.

• Create filing indexes and keep correspondence lists up to date.

• Assist with the preparation of regulatory document templates, study binders, study communications, and presentations.

• Manage essential documents related to clinical, regulatory, and study matters, including study protocols and Informed Consent Forms.

• Support the initial release of study drugs, which involves reviewing regulatory packets and study-drug releases.

• Develop training materials that are specific to the study.

• Take part in the planning of investigator meetings.

• Communicate with sites to address any issues that arise.

• Manage incoming and outgoing shipments as necessary.

• Oversee and track monitoring visit reports.

• Monitor the progress of clinical trials and prepare status update reports accordingly.

• Engage in clinical data review at various levels, including case report forms, data listings, and report tables.

• Collect weekly updates and reports on enrollment.

• Assist the Project Manager in organizing project meetings, which includes scheduling calls, gathering updates, preparing agendas, and drafting minutes.

• File and conduct quality control on trial master files.

• Ensure timely and accurate filing/uploading of documents into the eTMF.

• Review and maintain records of study-team training.

• Update any changes in study team members and the Study Contact Sheet.

• Complete assigned Study Plan Checklists.

• Identify and appropriately escalate issues as they arise.

• Serve as a central point of contact for project communications and documentation.

• Conduct data entry into designated clinical tracking systems.

• Carry out other related duties as necessary.

⛳️ Requirements

• A high school diploma/certificate or an equivalent educational qualification is required.

• At least 2 years of clinical research experience is necessary.

• A general understanding of relevant clinical research regulations, including GCP and ICH guidelines.

• Proficiency in Microsoft Office is essential.

• Proven organizational and coordination abilities with a keen eye for detail.

• Strong communication skills, both written and verbal.

• Effective time management and organizational capabilities.

• Attention to detail and accuracy in all tasks.

• A strong customer service mindset.

• Capability to work efficiently while managing multiple tasks at once.

• Ability to foster a teamwork-oriented environment with a positive attitude.

🏝️ Benefits

• Option for remote work.