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Inhouse Clinical Research Associate - Serbia

May 2, 2026

Brief Position Description:The <a name="_Hlk90558202">Inhouse Clinical Research Associate </a>(IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.Minimum Qualifications & Experience:<ul style="list-style-type: disc;"><li>Relevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.</li><li>Entry to less than 2 years’ experience as inhouse CRA or relevant roles. </li></ul>Responsibilities:<ul style="list-style-type: disc;"><li>Support the clinical team’s inhouse activities on assigned projects. </li><li>Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.</li><li>Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs. </li><li>Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF’s, ensuring accuracy and completeness of the data.</li><li>Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.</li><li>May assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits. </li><li>May assist IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close out phase.</li><li>May assist with site specific Clinical Trial Agreement (CTA) and budget negotiation. Prepare and amend the CTA within agreed negotiation parameters and policies. Work closely with the Project Management, Clinical Operations and Legal teams to facilitate timely execution of CTA.</li><li>Prepare and update site Subject Visit Template (SVT)’s in accordance with site budgets.</li><li>Take a responsibility of submission and tracking of Investigator payments in CTMS and any finance system. Complete study finance reconciliation as requested by the CRA, ensuring subjects activities are updated.</li><li>Assist with vendor management updates, tracking and payments as requested by the CRA including updating laboratory normal reference ranges. As required also support sourcing supplies, shipment arrangement and customs clearance. </li><li>As required, may contact site staff/Investigators on behalf of the CRA to request information or resolve issues. </li><li>Take responsibility of document archiving as per Novotech SOPs.</li><li>Where required, track and report study SUSARs/CIOMS to the relevant stakeholders, i.e., Regulatory Authorities, Investigators and Sponsors according to the Safety Management Plan and Clinical Monitoring Plan. </li><li>Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs.</li><li>Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.</li><li>Be aware of and adhere to company processes in areas relevant to an Inhouse Clinical Research Associate. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role.</li></ul> Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. <div style="margin-top:5pt;margin-bottom:10pt"> Novotech is a global full-service clinical Contract Research Organization (CRO). At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do. </div> <div style="margin-top:5pt;margin-bottom:10pt"> Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact. </div> <div style="margin-top:5pt;margin-bottom:10pt"> </div> <div style="margin-top: 5pt; margin-bottom: 10pt"> At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. At Novotech you will work alongside empowered teams with a shared commitment to success. </div> <div style="margin-top: 5pt; margin-bottom: 10pt"> <ul style="margin-bottom: 0cm"> <li>Strategic vs transactional mindset.</li> </ul> </div> <div style="margin-top: 5pt; margin-bottom: 10pt"> <ul style="margin-bottom: 0cm"> <li>Ability to gain insights and make proactive decisions quickly.</li> </ul> </div> <div style="margin-top: 5pt; margin-bottom: 10pt"> <ul style="margin-bottom: 0cm"> <li>Culture that fosters partnership and collaboration, where every voice is heard and valued.</li> </ul> </div> <div style="margin-top: 5pt; margin-bottom: 10pt"> <ul style="margin-bottom: 0cm"> <li>Ongoing support from senior stakeholders and leadership team.</li> </ul> </div>.

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...