Medpace is an industry-leading, full-service Clinical Research Organization (CRO) dedicated to advancing global clinical development for the biotechnology, pharmaceutical, and medical device industries. With its headquarters in Cincinnati, Ohio, and operations spanning over 40 countries, Medpace employs more than 5,000 individuals. The company’s mission is to accelerate the development of safe, effective medical therapeutics by combining scientific expertise with a disciplined, systematic approach. Medpace has a proven track record in areas such as oncology, cardiology, metabolic diseases, endocrinology, CNS disorders, and anti-viral/anti-infective research.
Job Overview: Study Start-Up Submissions Coordinator
Medpace is seeking a dedicated Study Start-Up Submissions Coordinator to join its Clinical Operations team in Navi Mumbai, India. This full-time, office-based role is essential for managing tasks and projects that contribute significantly to the company’s success in clinical research.
Key Responsibilities
The Study Start-Up Submissions Coordinator will play a pivotal role in supporting site activation activities and ensuring successful submissions. Key responsibilities include:
- Site Activation: Conduct activities required for activating investigative sites for clinical trials across various phases.
- Regulatory Submissions: Prepare, review, and submit necessary documentation to regulatory agencies, ensuring adherence to guidelines.
- Collaboration: Maintain communication with global study teams and personnel to provide updates on study progress.
- Risk Management: Identify and mitigate potential risks associated with site activation.
- Expert Guidance: Offer expertise to global study teams regarding ethics and regulatory submission requirements.
- Documentation Review: Review and finalize essential site activation documents.
- Main Contact: Serve as the primary contact for ethics and regulatory submission activities and site activation.
- Regulatory Compliance: Ensure all submissions comply with relevant regulations and guidelines.
- Advisory Role: Advise sponsors on any changes in regulations and compliance standards.
- Tracking and Filing: Track submission progress and ensure timely filing of related documents.
Qualification Requirements
The ideal candidate for this position should possess the following qualifications:
- Education: A Bachelor’s degree in a scientific field or equivalent education and experience.
- Experience: Minimum of one year of relevant experience at a CRO, pharmaceutical company, or investigative site.
- Technical Skills: Familiarity with Microsoft® Office and ICH-GCP guidelines.
- Regulatory Knowledge: Hands-on experience in preparing, reviewing, and submitting documentation to ethics committees and regulatory agencies, including formulating responses to queries.
- Communication: Excellent organizational and communication skills.
- Language Proficiency: Strong command of English.
Key Skills
- Organization & Multitasking: Ability to effectively manage multiple tasks and deadlines.
- Attention to Detail: Ensure accuracy and compliance in all regulatory submissions.
- Problem-Solving: Identify risks to site activations and propose solutions to mitigate them.
- Collaboration: Work collaboratively with global teams and local sites to support successful study initiation.
- Adaptability: Stay informed about changes in regulations and implement necessary adjustments.
