Associate Clinical Compliance Manager
- Experience Level
We are the UK’s largest early Phase Contract Research Organisation (CRO) conveniently based in central London with excellent transportation links. We invite you to join a motivated team of like-minded, talented, innovative individuals driving towards excellent in clinical research.
We are seeking enthusiastic individuals to join our team of in-house clinical monitors. This is an excellent opportunity to gain experience in a fast paced CRO and enhance your career within a well-structured research environment.
Key duties and responsibilities:
• To check the quality of clinical procedures performed and study data collected to ensure it is complete, correct and conforms to all requirements, ICH GCP Guidelines and other applicable regulations as well as meeting the study criteria defined within the protocols, operations manuals and Richmond's standard operating procedures
• To monitor and enforce clinical compliance with ICH GCP and all applicable regulations
• To maintain personal training records to the highest standards, ensuring that all Quality Control (QC) examinations are current and that the reading of all SOP’s/SOM’s/CSP’s is up to date
• To perform on the spot QC of data collected in line with daily procedures prior to the end of each shift
• Coordination and management of staff members allocated to a project to ensure they have adequate time for QC work
• To assist Research Physicians to ensure reject files are ready for sign off in timely manner
Additionally you will be:
• Working with the Medical Administrators to ensure Research Physician queries are resolved in a timely manner
• Interfacing with Data Management team to resolve eCRF/Data Base queries
• Resolving queries with CRAs
• BSc or above in Life Sciences or Nursing or Pharmacy (not necessarily registered in the UK)
• Minimum 1 year experience in either Clinic or monitoring of clinical data
• Good knowledge of ICH GCP guidelines
• Good knowledge of MHRA early phase accreditations
Applicants must be fluent in English both oral and written. We also welcome applicants whose first language is Japanese. Attention to detail, self-motivation, enthusiasm and the ability to work well in a team as well as individual are essential.
In return we offer excellent opportunities for training, a generous remuneration package and a generous holiday allowance.
If you are interested in the role and would like to apply, please follow the link below and register your interest directly on our BambooHR website. You will be asked to supply a CV and basic contact details.
While we endeavour to respond to each candidate individually, the high volume of applications that we anticipate for this role may make this unfeasible. If you have not heard back from us within two weeks of sending your application, please assume that on this occasion, you have not been successful.