As a CRA II, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.
This is a remote role.
Your responsibilities will include:
Conducting and reporting all types of onsite monitoring visits
Driving the study startup phase (if applicable)
Performing CRF reviews, source document verification and query resolution
Be responsible for site communication and management
Supervising study activities, timelines, and schedules for each site
Acting as a point of contact for in-house support services and vendors
Supporting quality control, such as compliance monitoring and reports review
Participating in feasibility research
Supporting the regulatory team in preparing documents for study submissions and regulatory approval
BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
Independent on-site monitoring experience in the UK, ideally on multiple projects at a time
Demonstrable experience in all types of monitoring visits in Phase II and/or III
Strong written and verbal communication skills
Experience supporting Oncology studies is beneficial, but not essential
Intermediate to Advanced knowledge of MS Office
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills are essential
As you will be monitoring multiple sites, you must have a full and clean driver's license, and the ability to travel.
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.
PSI is a leading Contract Research Organisation with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Originally posted on Himalayas