Job DescriptionAre you a Senior CRA / Lead CRA looking for that step up but frustrated at the lack of options of going to a PM due to not having ‘previous PM experience’? Then this is an ideal dual role to help you develop to that PM level as soon as possible for a soft entry to a PM role with genuine progression to PM swiftly in a HOME based role.
Managing clinical projects from commencement to completion, you will be the interface between clients and sites, managing the multiple trials across many therapeutic areas at any one time ensuring they studies are delivered on time and within budget. You will serve as the point of contact for all sponsor related queries while also overseeing a team of SCRAs and CRAs. This role is perfect for someone who is driven and likes working in a fast paced environment.
SCRA Core Responsibilities
Coordinate allocated projects and project activities in accordance with guidelines and SOPs with minimal supervision.
Coordinate the required activities of stakeholders in the clinical project management process including sponsor, site and monitors.
Monitor all aspects of studies to ensure compliance with GCP, study protocol and regulatory requirements and prepare monitoring reports.
Perform Study Initiation, On-study and Study Close-out activities.
Verify subject records, review essential documents, perform investigational product accountability, meet with site personnel and ensure procedures are conducted per the protocol.
Site management between monitoring visits, contact sites, ensure adequate enrolment and document collection as required.
Develop and review study protocols and other study related documents.
Prepare documents related to a clinical trial.
The Senior Clinical Research Associate (SCRA) performs activities associated with the evaluation, initiation, monitoring and close out of clinical trials to ensure the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICHGCP guidelines and other applicable regulatory requirements.
Challenging and stimulating environment where what you do matters
Diverse and inclusive culture with a strong emphasis on team collaboration
Training and career development opportunities
Please get in touch to hear more about the role!
Clinical Project Manager / Senior Clinical Research / SCRA / Trial Manager