About Company
Propelling medical innovation forward demands meticulous attention to detail and unwavering dedication. At career.imfdirectgov, we champion Clinical Research Associates who are passionate about the rigorous oversight and ethical conduct of clinical trials. Join a dynamic team where your expertise directly shapes groundbreaking therapies, working within a supportive framework designed for professional growth. We are committed to fostering an environment where your contributions are recognized and your career trajectory is accelerated. For a CRA, this means impactful work in a collaborative, science-driven setting.
Job Description
We are seeking a highly motivated and experienced Clinical Research Associate (CRA) to join our dedicated team in Perth, Perth and Kinross. As a CRA, you will play a pivotal role in ensuring the successful execution, monitoring, and management of clinical trials across various therapeutic areas. This position requires a meticulous professional with a strong understanding of ICH-GCP guidelines, local regulations, and a commitment to maintaining the highest standards of data integrity and patient safety.
Your expertise will be instrumental in driving forward critical research, from site initiation to close-out. You will serve as the primary point of contact for clinical sites, fostering strong relationships and providing comprehensive support to ensure study objectives are met efficiently and ethically. This is an exciting opportunity for a seasoned CRA looking to make a significant impact on advancing healthcare solutions within a supportive and collaborative environment. If you are passionate about clinical research and possess the skills to navigate complex trial protocols with precision, we encourage you to apply and contribute to our mission of improving lives through scientific discovery.
Key Responsibilities
- Conduct comprehensive site qualification, initiation, interim monitoring, and close-out visits in accordance with study protocols, ICH-GCP, and SOPs.
- Verify the accuracy and completeness of case report forms (CRFs) against source documents.
- Ensure the timely submission of all required documentation from investigational sites.
- Provide training and ongoing support to investigational site staff regarding study protocols, regulatory requirements, and data collection procedures.
- Review and manage essential documents at sites and centrally, ensuring compliance with regulatory requirements.
- Assess subject recruitment and retention rates, identifying and addressing potential issues.
- Facilitate communication between investigational sites and central project teams.
- Prepare accurate and timely monitoring visit reports and follow-up letters.
- Participate in investigator meetings and other project-related training sessions.
- Identify, document, and report protocol deviations, adverse events, and serious adverse events according to study procedures and regulatory requirements.
- Assist with the resolution of data queries in collaboration with data management teams.
Required Skills
- Minimum of 2 years (24 months) of independent clinical monitoring experience in Phase II/III clinical trials.
- Bachelor's degree in a life science, nursing, pharmacy, or a related healthcare field.
- In-depth knowledge of ICH-GCP guidelines and applicable regulatory requirements (e.g., MHRA, EU Directives).
- Proven ability to manage multiple study sites and priorities effectively.
- Excellent communication, interpersonal, and presentation skills.
- Strong analytical and problem-solving abilities.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Valid driving license and willingness to travel extensively within the region and occasionally nationally.
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific discipline.
- Experience across various therapeutic areas, particularly oncology, neurology, or rare diseases.
- Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Certification as a Clinical Research Associate (e.g., CCRA).
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive private health insurance.
- Generous pension scheme contributions.
- 25 days annual leave plus public holidays.
- Company car allowance or use of a company vehicle.
- Professional development and continuing education opportunities.
- Life assurance and income protection.
- Employee assistance program.
- Supportive and collaborative work environment.
- Opportunity to work on cutting-edge clinical trials.
How to Apply
To embark on a rewarding career with career.imfdirectgov, please click on the application link below. Submit your detailed CV and a compelling cover letter outlining your relevant experience and why you are the ideal candidate for this Clinical Research Associate position. We look forward to reviewing your application.
