ABOUT US

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 an In-House Clinical Research Associate to join our Clinical Operations team where you will be responsible for site start-up, including performing site identification, and assisting with the distribution and collection of essential documents in accordance with the Green Light Process SOP and ICH-GCP. You will also support with submissions to local regulatory authorities, localisation of patient-facing materials and assembly of the Investigator Site File. Throughout the duration of the Clinical Trial, you will support the Clinical Trial Manager and study team with in-house site management activities by tracking and providing status updates, up-to-date information and documents to the Investigator sites, CRA/CTM and the Project Management team. In addition, throughout the duration of the trial, you will ensure the completeness and compliance of (e)TMF, as per the applicable SOPs.

KEY ACCOUNTABILITIES

• Investigator site identification, feasibility and distribution and collection of Confidential Disclosure Agreement (CDA’s).
• Collect and review the Essential Documents and complete the site Green Light Forms to enable sites to be set-up and activated.
• Prepare Investigator Site Files and customise for Country and Sites.
• Manage access for Electronic Systems for internal and external study team members.
• Communicate Institutional Research Board/Independent Ethical Committee (IRB/IEC) Submission/Approval status with investigator sites and track status.
• Management, QC and filing of Essential Documents in TMF/eTMF.
• Upkeep of Vault Clinical with up-to-date information, in both the CTMS and eTMF, and contribute to workflows as applicable.
• Support the resolution of Follow-up items for sites raised by CRAs.
• Prepare, reconcile, and archive trial related documents at study closure.
• Coordinate the regular TMF reviews and follow-up to resolve any ongoing issues and maintain the Expected Document List
• Assist with the review/approval of country and site-specific changes to Patient Informed Consent Document (PICD) and other patient-facing documents.

SKILLS REQUIRED

ESSENTIAL

• Excellent written and verbal English communication skills; fluent in host country language
• Strong computer skills, proficiency with MS Office Word/Excel
• Previous Clinical Research Experience, or Strong Scientific Background (e.g. Previous science based employment or education)
• Ability to be flexible and multitask
• A proactive approach to work and the ability to work independently.

DESIRABLE

• Undergraduate degree in Nursing, Life Sciences or equivalent work experience
• Previous Clinical Research Experience
• Experience with CTMS/eTMF/EDC systems
• Prior Working Knowledge of ICH-GCP

WHY YOU SHOULD JOIN US

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.