Clinical Research Associate- Regulatory Submissions

Medpace Inc.
Full Time
₹6 Lakhs - ₹8 Lakhs
Mumbai
Posted 1h ago

Clinical Research Associate- Regulatory Submissions

Medpace Inc.

Job description

Want to build your career in clinical research and regulatory affairs? Check out this job vacancy by Medpace for the role of Clinical Research Associate- Regulatory Submissions.

 Company Description 

Medpace is a global contract research organization (CRO) providing clinical development services to the biotechnology, pharmaceutical and medical device industries. The company, based in Cincinnati, Ohio, offers a full spectrum of clinical trial services from Phase I to IV across a wide range of therapeutic areas including oncology, cardiology, endocrinology and central nervous system disorders.

 Job Summary 

Medpace is seeking a Clinical Research Associate to join the Clinical Operations team in Navi Mumbai, Maharashtra. The Regulatory Submissions Coordinator facilitates clinical trial start-up by organizing the country-specific regulatory and ethics submissions required to activate investigative sites. Requires relevant expertise in regulatory writing and tight interaction with local sites, regulatory bodies, sponsors, and worldwide study teams. The role is predominantly office based, with hybrid options available, depending on eligibility.

 Key Responsibilities 

  • Coordinate the regulatory activities required to activate sites for the conduct of clinical trial investigations in all phases.

  • Prepare, evaluate and submit documentation to the appropriate regulatory authorities and ethics committees.

  • Review and finalize important documentation required before the start of the clinical trial sites.

  • Serve as a primary contact for ethics committee and regulatory submission activities.

  • Participate in the study start-up and site activation activities with investigation sites.

  • Collaborate closely with global study teams to communicate submission progress and address regulatory documentation difficulties.

  • Identify any delays or risks impacting site activation and take appropriate action to mitigate.

  • Give regulatory counsel to internal study teams on ethics submissions and local needs.

  • Keep sponsors informed of any changes in regulatory requirements and potential impact on research activity.

  • Track document submission status and verify documents are filed within time frames.

  • Prepare responses to questions from ethics committees and regulatory bodies.

 Educational Qualification 

  • A bachelor’s degree in a science discipline is necessary;.

  • Experience in regulatory writing in clinical research is required.

 

 Skills Required  

  • Understanding of Indian clinical research rules and regulatory submission procedures.

  • Practical knowledge of CDSCO and DCGI requirements.

  • Experience with preparation, review and submission of regulatory documentation.

  • Experience with ethics committee submissions and clinical trial site activation.

  • Ability to understand regulatory rules and translate them into study requirements.

  • Excellent verbal and written communication abilities.

  • Demonstrated experience working with worldwide clinical research teams and investigative locations.

  • Ability to identify submission-related hazards, and facilitate avoiding delays.

  • Strong document review skills and attention to detail.

  • Time management skills to handle various submissions and deadlines

  • Ability to develop coherent answers to regulatory authority questions.

  • Adaptability to regulatory changes or changes in research time frames.

 
Salary Structure 

The average salary of a Clinical Research Associate- Regulatory Submissions at Medpace ranges between Rs.6 Lakhs to Rs.8 Lakhs per year.

 
Career Development 

This role gives experience in regulatory affairs, clinical trial start up and ethics committee submissions. Medpace also emphasizes organized training, mentoring, ongoing learning and clear career paths that can assist advancement into senior regulatory coordinating or regulatory submissions management.

 How to Apply 

  • Go to our job portal and look for the Clinical Research Associate- Regulatory Submissions position.

  • Open the listing to view qualifications and location details.

  • Fill in your information and upload your resume.

  • Submit your application.

 

Employment Type: Full Time
Industry: Healthcare
Role Category: Clinical Research
Application: External (Company Site)

Education

Bachelor's Degree

Key Skills

Clinical ResearchNon Clinical JobsMedical Affairs

Market insights & trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

Frequently Asked Questions

Everything you need to know about the process

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