Senior Clinical Research Associate

We are seeking an experienced and highly driven Senior Clinical Trial Associate (Senior CTA) to join our clinical research team. The Senior CTA will play a critical role in independently supporting and overseeing the planning, execution, and management of clinical trials, ensuring full compliance with regulatory requirements, GCP guidelines, and company protocols.

This role requires strong operational expertise, excellent stakeholder management, and the ability to mentor junior team members while collaborating closely with cross-functional teams.

Key Responsibilities:

- Independently support and coordinate clinical trials from study initiation through close-out.
- Oversee and maintain comprehensive trial documentation, including protocols, investigator brochures, informed consent forms, and amendments.
- Ensure strict compliance with ICH-GCP, regulatory guidelines, and internal SOPs across all trial activities.
- Lead and support preparation, review, and submission of regulatory documents to ethics committees and regulatory authorities.
- Manage and track trial-related materials, including investigational products, essential documents, and study supplies.
- Support and coordinate site selection, site activation, monitoring activities, and ongoing site communications.
- Act as a primary point of contact for investigators, site staff, vendors, CROs, and internal stakeholders to ensure smooth trial operations.
- Organize and actively participate in clinical team meetings, prepare minutes, track action items, and drive timely follow-ups.
- Review, process, and track study invoices, contracts, and budget-related activities in coordination with finance and legal teams.
- Maintain Trial Master Files (TMF) to audit-ready standards and support inspections and audits as required.
- Provide guidance and informal mentoring to junior CTAs or clinical team members, as applicable.

Qualifications & Requirements:

- Bachelor’s degree in life sciences, healthcare, or a related field (Master’s degree is a plus).
- 3–6 years of experience in clinical research, preferably in a CTA or similar clinical operations role.
- Strong working knowledge of ICH-GCP, FDA regulations, and global clinical research standards.
- Proven ability to manage multiple studies or complex trial activities independently.
- Excellent attention to detail, organizational, and documentation skills.
- Strong communication, coordination, and stakeholder-management abilities.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and G Suite.
- Ability to prioritize, multitask, and perform effectively in a fast-paced environment.

Preferred Qualifications:

- Experience working in pharmaceutical, biotech, or CRO environments.
- Clinical research certification (e.g., ACRP, SOCRA) is highly desirable.
- Exposure to audits, inspections, or global/multi-site trials is an advantage.

Benefits:

- Competitive salary and benefits package.
- Opportunities for professional growth, leadership exposure, and career advancement.
- A collaborative, inclusive, and mission-driven work environment.

Interview Process:

HR Screening → Interview with Hiring Manager → Interview with Founder

Application Instructions:

Please submit your CV and any relevant portfolio materials to

Divjyot.kaurlth