Medpace is a full-service Clinical Research Organization (CRO) committed to accelerating the global development of safe and effective medical therapeutics. Founded more than 30 years ago, Medpace works with biotechnology, pharmaceutical, and medical device industries to conduct Phase I-IV clinical trials. With its headquarters in Cincinnati, Ohio, the company operates in over 40 countries and employs more than 5,000 experts. Medpace offers a dynamic work environment focused on delivering exceptional results that make a meaningful impact on patients’ lives.
Position Overview: Study Start-up Submissions Coordinator
Medpace is currently hiring a Study Start-up Submissions Coordinator to join its Clinical Operations team in Navi Mumbai, India. This role plays an essential part in the activation of clinical trial sites, ensuring that regulatory submissions align with local and global compliance standards. As a coordinator, you’ll have the chance to build a rewarding career by supporting study activations across different phases of clinical research.
This position not only offers exciting projects but also provides career growth opportunities, competitive benefits, and a hybrid work environment that promotes work-life balance.
Key Responsibilities of the Study Start-up Submissions Coordinator
- Oversee the activation of investigative sites for clinical trials at all stages.
- Prepare, review, and submit essential documents to Ethics Committees and Regulatory Authorities.
- Communicate with global study teams to report progress and provide updates.
- Identify risks to site activation and implement effective solutions.
- Offer guidance to global teams on regulatory submissions and compliance.
- Maintain direct communication with investigative sites throughout the start-up and activation phases.
- Ensure that submissions comply with regulatory standards such as ICH-GCP guidelines.
- Provide advisory support to sponsors on regulatory changes.
- Monitor submission timelines and track documentation to ensure deadlines are met.
Qualifications for the Role
- Bachelor’s degree in a science-related field or an equivalent mix of education and experience.
- At least one year of experience working with a CRO, pharmaceutical company, or investigative site.
- Hands-on experience in preparing and submitting documents to Ethics Committees and Regulatory Agencies.
- Proficiency in Microsoft Office tools.
- Solid understanding of ICH-GCP guidelines and regulatory requirements.
- Strong communication and organizational skills.
- Ability to write responses to queries from regulatory authorities.
- Fluency in English is required.
Skills You Need to Succeed
- Attention to detail to ensure error-free submissions.
- Project management abilities to handle multiple submissions simultaneously.
- Collaboration skills to work effectively with global teams and investigative sites.
- Problem-solving skills to address and resolve risks during site activation.
- Adaptability to navigate changing regulatory landscapes.