Clinical Trial Coordinator
Closed Loop Medicine was founded in 2017. We operate at the interface of biotech, pharma and digital technology industries, using the concept of convergence to create new closed-loop models of care pathways, integrating feedback to optimise outcomes for patients and health systems.
We have a new opportunity for an experienced Clinical Trial Coordinator. You will be responsible for providing oversight of clinical projects and maintaining relationships with operational and commercial focus. You will work closely with external clients, internal project team members and suppliers to ensure the clinical studies are delivered on time and within budget.
The successful candidate will have experience of a similar role ideally within a small CRO/Pharma/Academic environment and must have worked on commercial trials.
Clinical Trial and Observational Study Coordination
Coordinate the set-up, protocol development and conduct of clinical research projects to agreed timelines, scope and budget, to ensure data integrity, and adherence to contract and protocol.
Liaise with required clinical trial consultants.
Prepare documents needed for the submissions to Research Ethics Committees and MHRA (if applicable), and reporting (project progress and financial) as needed.
Coordinate the day-to-day running of trials or clinical project activities.
Work with, and provide regular updates to, trial principal investigators and CLM management team to ensure that they are fully informed of the trials and/or studies.
Identify any challenges/barriers to executing the trials/studies and ensure that trial principal investigator and team are aware of these and work together to find a resolution.
Ensure all necessary documentation is created, completed and archived as required.
Governance & Quality
To work at all times according to regulations as described in ICH Good Clinical Practice (GCP) and in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 as necessary.
Produce, develop and implement Standard Operating Procedures (SOPs) for CLM.
Assist in the maintenance of CLM QMS files.
Ensure accurate records are kept and archived as needed and that any documentation that needs to be shared with study sites is done so in a timely fashion.
Prepare documents for reporting (project progress and financial) as needed and to track and update progress on project plans.
Support with budgeting and contracts.
Organise meetings and support investigator and CRO meetings.
Education to degree level or equivalent in a science or related subject.
Experience of providing administrative support in a fast-paced environment
Experience of collecting, handling and tracking data and managing complex information or projects.
Motivated, enthusiastic self-starter who can work independently and collaboratively in a dynamic team environment.
Good written and verbal communication skills.
Organised with an ability to work well under pressure and to challenging timelines.
High level of attention to detail and accuracy.
Contract: 15 month fixed term full time contract.
We are located in London, very conveniently next to Angel tube station. We offer competitive salaries and company pension.
We believe strongly that the team is fundamental to both our personal fulfilment and the company’s success. From the start, we have embedded an extremely supportive and cohesive ethos into the company. These values will also be embedded in our products, helping to change both patients’ lives and society for the better.
To apply please send your CV and a covering letter to firstname.lastname@example.org. Please quote job reference CLM1901. Closing date for applications is 24 May 2019.