Clinical Study Start-Up Associate Job For BSc Life Science At ICON

Clinical Study Start-Up Associate Job For BSc Life Science At ICON

Clinical Study Start-Up Associate Job For BSc Life Science At ICON. The Icon is a multinational clinical research organization that is now Hiring a Clinical Study Start-Up Associate (SSUA-I & II) / Study Support Assistant (SSA). Interested candidates can check out the details below and apply online.

Job Position: SSUA- I & II(Study Start-up Associate)/ SSA (Study Support Assistant)

Company Name:  ICON

Job Location: Bangalore, India

Job id: JR108915

Job Category: ICON Full Service & Corporate Support

Job Type: Office Based

SSUA-I & II(Study Start Up Associate)/ SSA (Study Support Assistant):

The Role:

• Review of site level essential documents ensuring that Sponsor and Investigator obligations are being met and are in compliance with ICON SOPs/WIs, Sponsor SOPs, applicable country requirements and ICH/GCP guidelines.
• Update systems in a timely and accurate way, maintaining site-related data in applicable clinical systems according to procedures and guidelines.
• Preparation and Submission of Investigational Product Release Pack.
• Ensure accuracy and timely completeness of Trial Master File (TMF) documents by submitting the documents for filing to TMF during start-up.
• Perform timely and accurate task progress communication.
• Be highly organized in an environment with shifting priorities.
• Interact successfully with internal stakeholders.
• Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study- specific processes, local regulatory requirements.
• Flexible to support on various other tasks apart from document management process
• To review and negotiate clinical site investigator contracts and budgets.
• Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
• Prepare and coordinate preparation of contractual documents and correspondence
• Facilitate the indemnification process between the study sponsor and the site.
• Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).

Qualification:

• Bachelor’s Degree in a life science related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
• Knowledge of ICH GCP and Prior clinical research experience with a minimum of 1-7 years’ experience in Essential Document review, filing documents in TMF and checking TMF completeness and readiness.

APPLY ONLINE

Here are five Possible interview questions along with their sample answers for Clinical Study Start-Up Associate (SSUA-I & II) / Study Support Assistant (SSA) Job:

1. Question: Can you describe your experience in ensuring compliance with ICON SOPs/WIs, Sponsor SOPs, applicable country requirements, and ICH/GCP guidelines while reviewing site level essential documents? Answer: In my previous role as a Study Start-Up Associate, I was responsible for meticulously reviewing site level essential documents to ensure adherence to ICON SOPs/WIs, Sponsor SOPs, country-specific requirements, and ICH/GCP guidelines. I would cross-reference each document with the relevant guidelines and check for any discrepancies or missing information. Additionally, I would provide feedback to the site teams and investigators, helping them rectify any issues, and ensuring that all obligations were met in a compliant and timely manner.

2. Question: How do you manage and maintain site-related data in applicable clinical systems? Can you provide an example of a challenging situation you encountered and how you resolved it? Answer: To manage and maintain site-related data, I follow the standard procedures and guidelines set by ICON. This involves updating the clinical systems with accurate and timely information regarding site progress, document submission, and other relevant details. One challenging situation I faced was when there was a technical issue with the clinical system, and I couldn’t update the site data for several days. To resolve this, I immediately escalated the problem to the IT department and ensured regular communication with the internal stakeholders about the issue. I also kept manual records during the downtime to ensure data integrity and later updated the system once it was back online.

3. Question: How do you ensure the Trial Master File (TMF) documents are complete and filed in a timely manner during the study start-up phase? Answer: Ensuring the completeness and timely filing of TMF documents is crucial for study success. I make it a priority to meticulously review each document before submission, ensuring they meet all the necessary requirements. To stay organized, I maintain a checklist of essential documents and their status, regularly updating it as new documents are received and filed. I also collaborate closely with site personnel and the TMF team to address any missing or incomplete documents promptly. This proactive approach helps maintain a robust and up-to-date TMF throughout the study start-up phase.

4. Question: How do you handle shifting priorities and manage tasks efficiently in a fast-paced environment? Answer: Being highly organized and adaptable is essential in managing shifting priorities. To efficiently handle multiple tasks, I first prioritize them based on deadlines and importance. I set realistic timelines for each task, allowing some buffer for unforeseen challenges. Regular communication with team members and stakeholders helps me stay updated on any changes and adjust my workflow accordingly. Moreover, I keep detailed notes and checklists to track progress and ensure no critical tasks are overlooked. This structured approach allows me to effectively manage my workload even in a fast-paced environment.

5. Question: As an SSUA, you are expected to review and negotiate clinical site investigator contracts and budgets. How do you approach these tasks to ensure successful outcomes? Answer: Reviewing and negotiating contracts and budgets requires a thorough understanding of the study requirements, sponsor expectations, and regulatory guidelines. I start by carefully analyzing the study protocol and identifying the specific needs of each clinical site. This enables me to tailor the contract and budget to meet the site’s requirements while adhering to the sponsor’s guidelines. During negotiations, I adopt a collaborative approach, working closely with the site personnel and sponsors to reach mutually beneficial agreements. I also ensure transparency in the process, clearly communicating any changes or adjustments to the involved parties. By maintaining open communication and leveraging my expertise in study budgets, I strive for successful outcomes that benefit all stakeholders involved in the process.

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