Senior Clinical Research Associate United Kingdom

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds… ClinChoice is searching for a Senior Clinical Research Associate to strengthen the team of one of our clients, a dynamic and innovative biotech company that offers new perspectives in dermatology. This will be a full-time position, and we are open to receiving applications from both employees for initially a Fixed Term Contract or Freelancers with a limited company. ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Main Job Tasks and Responsibilities

• Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
• Site evaluation visits, initiation visits and ensure follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
• Train site staff in all study procedures.
• Conduct periodic monitoring visits, including completion of monitoring visit report.
• Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
• Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.
• Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
• Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
• Act as the main contact person for the site in order to ensure close follow up.
• Provide general support to the Clinical Research Division on quality control of clinical data.
• Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned in a timely manner.
• Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
• May assist with contract negotiation with sites on study budget after appropriate training.
• Assist with the preparation of the study, including CRF design/development, write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites.
• May support the submission process in the project including submission requirements, timelines, informed consent development, etc.

Education and Experience

• University Degree in scientific, medical or paramedical disciplines.
• Proven experience as a CRA, performing on-site monitoring activities.
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
• Fluent in English and local language(s).
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
• Willingness to travel.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.