Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we 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’ll 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. THE ROLE
We are looking for a Clinical Research Associate III to join our Clinical Operations team based remotely in the USA (West Coast/Moutain time zone) where you will be responsible for the setup of sites, budget proposals, and will liaise with the relevant authorities to ensure approvals are in place. You will monitor the progress of clinical trials onsite or remotely for complex studies, ensuring the trials are conducted, documented and reported in accordance with the protocol, standard operating procedures (SOPs), all applicable regulatory requirements and ICH-GCP. In this role you will work closely with sponsors, project managers and other members of the study team to ensure all 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. (eg. 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.
- 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.
- 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.
- 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, CTLs and PMs.
- Bachelor’s degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
- Experienced Clinical Research Associate
- Excellent communication skills
- Proficiency in written and spoken English and fluent in host country language
- Good knowledge of European 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
WHY YOU SHOULD JOIN US
- Previous CRO experience
- Good experience in CTMS, eTMF IXRS and EDC systems
- Advanced degree (Masters, MD, PhD)
- Experience as a Senior Clinical Research Associate
- Strong presentation skills
- Competent in clinical trial planning and metrics management
Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.
We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.
With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you. our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.