Our Mission:
Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.
We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.
The Role:
We are looking for a Senior Clinical Research Associate to join our Clinical Operations team where you will be responsible for the setup, monitoring, close out of sites, budget negotiations, and liaising with relevant authorities to ensure approvals are in place. Will be involved with more complex studies and challenging sites to monitor the progress of clinical trials onsite or remotely, to ensure the trials are conducted, documented and reported in accordance with the protocol, standard operating procedures (SOPs), all applicable regulatory requirements and ICH-GCP. Will work closely with Clinical Trial Managers (CTMs), sponsors, project managers and other members of the study team to ensure study deliverables are met within the project timelines.
Key Accountabilities:
- Contribute to site identification and feasibility activities.
- Responsible for all aspects of study site management. (e.g. Training site staff, ensure supply of study material, IMP and trial documents, recruitment updates, etc...).
- Responsible for collection and assessment of essential documents and perform reconciliation of Investigator Site File.
- Conduct pre-study visits, site initiation visits site monitoring visits and site closeout visits per SOPs/WPDs.
- Assesses IP accountability, dispensation, and compliance at the investigative sites.
- Prepare accurate and timely visit reports in accordance with the monitoring plan and/or SOPs.
- Collaborates with project functional leads as needed.
- Attends internal and external project calls as requested and per budget to proactively provide required site updates.
- Demonstrates working knowledge of applications and Systems (e.g. CTMS, eTMF, IVRS/IWRS and EDC).
- Facilitates site audits and audit finding resolutions.
- May supervise work of, or mentor, less experienced CRAs, based on Mentoring program.
- Serve as an observational visit leader.
- Provide feedback to management and cross-functional study team on any current or potential risks or problems affecting the conduct of the clinical trial.
- Feedback on any areas requiring improvement within the department and involvement in initiatives such as updating SOPs, Work instructions and Processes.
- Can be involved in other tasks as assigned by Management, CTMs and PMs.
- Escalate in timely manner any issue related to Quality or Data integrity.
Skills Required:
Essential
- Bachelor’s degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
- Previous experience as a Clinical Research Associate with strong demonstration of Clinical Research fundamentals
- Good experience in CTMS, eTMF IXRS and EDC systems
- Previous CRO experience
- Excellent communication skills
- Strong presentation skills
- Proficiency in written and spoken English; fluent in host country language
- Good knowledge of regional clinical research regulations and ICH-GCP
- Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge
- Ability to establish/maintain good relationships with sites/colleagues/clients
- Ability to make decisions independently / Strong problem-solving skills
- Highly developed mentoring and motivational skills
Desirable
- Advanced degree (Masters, MD, PhD)
- Competent in clinical trial planning and metrics management
About Us:
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.