Medpace BSc Job Opening – Applications Invited Online
Medpace BSc Job Opening – Applications Invited Online. Study Start up Submissions Coordinator job opening. BSc Life Sciences and biotechnology job opening. Medpace jobs. Interested and eligible candidates are requested to apply below.
Hey there, are you wondering what type of interview questions can be asked for the post of Study Start up Submissions Coordinator, then check them out below
Study Start up Submissions Coordinator
India-Navi Mumbai
Job Summary
We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you.
Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations
, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace teamResponsibilities
- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
- Prepare, review, and submit to Regulatory Agencies;
- Communicate with global study teams and personnel on study progress;
- Ability to effectively identify risks to site activations and mitigate as necessary;
- Provide expertise and guidance to global study teams in ethics and regulatory submissions;
- Review and finalize essential documents required for site activation;
- Act as a main contact for Ethical and Regulatory submission-related activities;
- Direct contact with investigative sites during the study start up and activation process;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise sponsors on changing regulations and compliance requirements; and
- Track submissions and ensure timely filing of documents.
Qualifications
- Bachelor’s degree in the science field or equivalent combination of education and experience;
- At least one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
- Excellent organization and communication skills;
- Knowledge of Microsoft® Office, ICH – GCP guidelines and regulatory guidelines;
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and
- Good command in English.
Hey there, are you wondering what type of interview questions can be asked for the post of Study Start up Submissions Coordinator, then check them out below
- What are some essential documents required for site activation?
Answer: Essential documents required for site activation may include signed contracts, investigator’s brochure, clinical study protocol, informed consent form, and regulatory documentation.
- How do you ensure that submissions comply with applicable regulations and guidance documents?
Answer: I ensure submissions comply with applicable regulations and guidance documents by keeping up-to-date with regulatory guidelines and policies, and by having a clear understanding of the regulatory requirements of each country where the study is being conducted. I also review all submissions thoroughly to ensure that they meet all requirements before submitting to regulatory authorities.
- How do you communicate with global study teams and personnel on study progress?
Answer: I use various modes of communication to keep study teams and personnel updated on the progress of the study. This may include email, phone calls, or virtual meetings. I also provide regular updates on submission timelines and any potential issues that may arise during the study start-up process.
- Can you provide an example of how you have identified risks to site activations and mitigated them?
Answer: One example of identifying risks to site activations and mitigating them is when I was working on a clinical trial in which a site was located in a country with complex regulatory requirements. I identified this as a potential risk to site activation and worked closely with the site to ensure that all necessary documentation was obtained and submitted in a timely manner. This allowed us to mitigate any potential delays in site activation.
- How do you stay informed about changing regulations and compliance requirements?
Answer: I stay informed about changing regulations and compliance requirements by regularly reviewing regulatory guidelines and policies from various regulatory authorities. I also attend training sessions and workshops to stay up-to-date on new regulations and requirements. Additionally, I collaborate with colleagues and other industry professionals to share knowledge and best practices.
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