(Senior) Clinical Research Associate

As a (Senior) Clinical Research Associate at Precision for Medicine, your key responsibilities will include monitoring clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP standards. You’ll coordinate study setup activities, facilitate regulatory submissions, conduct pre-study and initiation visits, and manage client interactions. Additionally, Senior CRAs will support project managers with larger trials and provide mentorship to junior staff members, ensuring that each study runs smoothly and successfully.

To apply for the (Senior) Clinical Research Associate position at Precision for Medicine, candidates must possess a life science degree or equivalent experience, with a minimum of one year of CRA experience in oncology. For those aiming for the Senior CRA title, two or more years of oncology experience and an understanding of financial management along with mentorship capabilities are preferred. Familiarity with study startup activities would also be advantageous.

Precision for Medicine is dedicated to fostering the growth of its (Senior) Clinical Research Associates by providing a supportive environment where employees are encouraged to voice their ideas and contribute to positive change. Beyond monitoring studies, CRAs will have the opportunity to mentor junior team members, participate in training sessions, and engage in proposal activities, all of which enhance professional development and broaden skill sets.

At Precision for Medicine, work-life balance is a priority. As a (Senior) Clinical Research Associate, you'll find that the workload is designed to be manageable, allowing for a fulfilling professional life while reducing the stress associated with excessive travel or high protocol numbers. This supportive approach leads to a culture of enjoyment and strong teamwork among colleagues, contributing to high retention rates.

While the (Senior) Clinical Research Associate position at Precision for Medicine primarily involves domestic travel within South Korea, some roles may require international travel, particularly for senior-level positions. The extent of travel will depend on the specific projects and duties assigned to the CRA, with a focus on ensuring comfort and balance in work commitments.

Start by detailing specific oncology studies you've monitored, focusing on your role, the regulations you followed, and how you ensured compliance. Highlight any challenges you faced and the solutions you implemented, demonstrating your problem-solving skills and your dedicated approach to quality assurance.

Explain that preparation for site visits involves meticulous planning, including reviewing study protocols and case report forms, assessing prior visit reports, and ensuring that all required documents are ready. Mention your proactive approach to anticipating potential issues and your adaptability to changing circumstances.

Discuss your time management techniques, emphasizing your ability to prioritize tasks based on urgency and importance. You can also mention using project management tools to stay organized while ensuring that communication with your team is clear and consistent.

Outline your thorough understanding of ICH-GCP guidelines and how you implement them daily. This can include conducting regular training sessions, maintaining updated study files, and conducting site audits to ensure adherence to regulatory requirements.

Provide a specific example where you spotted a potential risk during a clinical study, how you recalibrated your strategy to address the risk, and the positive outcomes that resulted from your intervention, emphasizing the importance of foreseeing risks in clinical research.

Discuss your systematic approach to data verification, such as implementing double-checks at various study phases, ensuring thorough training for site staff, and maintaining clear lines of communication regarding data entry and reporting.

Highlight qualities such as attention to detail, strong organizational skills, excellent communication abilities, and a proactive mindset. You might also mention the importance of adaptability in staying up-to-date with regulatory changes and study protocols.

Emphasize the importance of clear communication, mutual respect, and building trust. Share techniques you use to foster positive working relationships, such as regular check-ins, effective conflict resolution tactics, and being open to feedback.

Discuss the pivotal role CRAs play in ensuring that clinical trials run smoothly, from monitoring compliance and quality to being a critical link between the study sites, the sponsor, and the regulatory bodies. Reflect on how this role is integral to the success of bringing new therapies to patients.

Share your passion for oncology and rare disease research, alongside an appreciation of Precision for Medicine's unique approach to clinical trials. Highlight how their values align with your career aspirations, particularly regarding teamwork, innovation, and a commitment to patient care.