Clinical Trial Assistant

We seek a highly motivated and detail-oriented Clinical Trial Associate (CTA) to join our clinical research team. The CTA will support the planning, execution, and management of clinical trials, ensuring compliance with regulatory guidelines and company protocols. This role requires strong organizational skills, excellent communication, and the ability to collaborate effectively with cross-functional teams.

Key Responsibilities :

Assist in the coordination and management of clinical trials from initiation to completion.

Maintain and update trial documentation, including investigator brochures, protocols, and informed consent forms.

Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and company policies.

Support the preparation and submission of regulatory documents to relevant authorities and ethics committees.

Track and manage trial-related materials, including investigational products and supplies.

Assist with site selection, activation, and ongoing monitoring activities.

Communicate with investigators, site staff, vendors, and internal stakeholders to facilitate smooth trial operations.

Organize and participate in clinical team meetings, taking minutes and following up on action items.

Assist in processing and tracking study invoices, contracts, and budgets.

Maintain trial master files (TMF) and ensure proper documentation for audits and inspections.

Qualifications & Requirements :

Bachelor’s degree in life sciences, healthcare, or a related field.

1-3 years of experience in clinical research, preferably in a CTA or similar role.

Knowledge of ICH-GCP guidelines, FDA regulations, and other relevant clinical research standards.

Strong attention to detail and organizational skills.

Excellent communication and interpersonal skills.

Proficiency in Microsoft Office (Word, Excel, PowerPoint) and G Suite.

Ability to multitask, prioritize, and work independently in a fast-paced environment.

Preferred Qualifications :

Experience working in a pharmaceutical, biotech, or contract research organization (CRO) setting.

Certification in clinical research (e.g., ACRP, SOCRA) is advantageous.

Benefits :

Competitive salary and benefits package.

Opportunities for professional growth and development.

A collaborative and inclusive work environment.

Application Instructions :

Please submit your CV and any relevant portfolio materials to Divjyot.kaur@sova.health.