Clinical Research Associate jobs

Job Purpose
Responsible for clinical data management activity including entry of clinical data, data query resolution at the clinical study site according to study protocol(s), ICH-GCP and local regulations and requirements. You will be a key interface amongst site-staff, study patients and external stakeholders, and perform a key role to enabling successful study performance at site.

This role includes a combination of working from home and on-site each week. Flexibility around on-site working is essential, and you may be required to attend the site at relatively short notice to ensure that the service is covered.

Main Responsibilities

• Leads on the completion of case report forms with clinical data on trial participants as per individual study requirements.
• Ensures completed case report forms, across a portfolio of studies, are of high quality, accurate and sent in a timely manner.
• Acts to resolve issues with source data and anomalous data at the time of reporting, reviewing against previously reported data as well as local and national normal ranges.
• Plans workload across a portfolio of studies using appropriate judgement with reference to specific deadlines, expected turn-around times and clinical importance.
• Organises and prepares documentation/records for audit and monitoring visits, facilitating sponsor representative/ CRA during monitoring visits.
• Maintains and coordinates essential records completion.
• Communicates effectively with research nurses, clinicians and other members of the Multidisciplinary Team (MDT) to answer trial related queries.
• Develops strong collaborative relationships with study site personnel, external stakeholders and the O4 Research team.
• Ensures that internal/external enquiries are dealt with professionally and effectively and maintains confidentiality at all times.
• Contributes to efficiency and process improvement, including the development of systems for improving source data collection.
• Understands and adheres to applicable site and O4 Research policies, procedures, standards and protocols, and Regulatory/ Legal (ICH-GCP, Statutory Instruments, Data Protection Act etc.) requirements.
• Maintains own professional development in conjunction with O4 Research’s services and those identified at Performance and Development Review.

Knowledge, Qualifications & Experience

• Life Sciences Degree
• Knowledge of ICH GCP, drug development process and clinical trials
• Minimum of one year's clinical trial experience (previous study site clinical data entry role is desirable)
• Experience in using EDC system(s)
• Experience in oncology and/or haematology studies is desirable

Personal Characteristics/ Key Competencies

• Self-motivated with ability to work independently, take initiative and problem solve, yet also work cooperatively as part of a team.
• Excellent organisation skills and time management skills, with proven ability to prioritise workload and work calmly under pressure.
• Proven ability to communicate effectively in writing and verbally
• Displays great tenacity, good eye for detail and an enthusiastic nature
• Flexible and responsive to new ideas in a changing environment and
• Demonstrate professionalism and present a positive image of O4 Research and the l site to the study wide stakeholders.
• Displays desire for professional and personal development and ability to identify own training needs.
• Approachable, personable and supportive of others.

NOTE: Expected contract length is 12 months with the potential for extension.

NOTE: Salary will be prorated for this part-time position

Job Type: Part-time

Pay: £34,000.00-£42,000.00 per year

Benefits:

• Company pension

Application question(s):

• What is the highest level of education you have completed?
• Do you have knowledge of ICH GCP, clinical trials and the drug development process?
• How many years of study site clinical data entry experience do you have?

Work Location: Hybrid remote in Cambridge CB2 0QQ