Summary Join a global top 5 biopharmaceutical company that works hard to provide prescription drugs that focus on producing innovative treatments in oncology, neuroscience, and Immunology. With an established Clin-ops team, you can gather support and learn from experienced consultants, with inspirational leadership. This world-renowned biopharma is looking to reduce its reliance on CROs and bring CRAs in-house, offering a fantastic academy with targeted career progression towards Senior CRA and above.This is apatient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing life-changing treatment to people worldwide. You could join the fight against disease and assist in the cutting edge, innovative development of new treatments, with opportunities for growth alongside the company.
Job Description The Clinical Research Associate is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to initiation, the development of a robust patient recruitment strategy, setting up a system, assessing compliance with regulations and the site’s capability to comply with the study needs and recruitment expectations, and problem solving to address and resolve site issues.
Responsibilities
Develop and write trial protocols (outlining purpose and methodology)
Present trial protocols to a steering committee
Design data collection forms, known as case report forms (CRFs)
Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
Identify and assess the suitability of facilities to use as the clinical trial site
Identify/select an investigator who will be responsible for conducting the trial at the trial site
Liaise with doctors, consultants or investigators on conducting the trial
Set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Location: Oklahoma
This role is an urgent need, the quicker we move the greater your chances of securing this role! These positions will be snapped up, looking for individuals who are ambitious, positive and want to work in a growing and exciting team. Do not miss out on this opening – apply below or contact Kush at Meet on 0203 0195957 or email directly to kush@peoplewithchemistry.com You can find out more about Kush & Meet at www.peoplewithchemistry.com
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