Clinical Research Associate( Manager )

Popscience Limited
South East England
£35k - £50k pa + DOE
02 Dec 2017
13 Dec 2017
Contract Type
Full Time
An exciting and rare new opportunity with a well renowned Research Institution in central London has become available.

We need an expert Office Based Clinical Research Associate ,Manager with experience in team management as well as study start-up, site initiation, regulatory and monitoring in Real World data through to site and study close-out.

As a Clinical Research Associate Manager you will oversee an in-house and remote team of Clinical Research Associates (CRAs), ensuring that the monitoring of studies are planned and implemented and that global country and site targets are achieved, in compliance with ICH/GCP, SOPs and all other applicable regulatory requirements.

For this long term contract we are looking for a candidate who is an experienced CRA Line manager . As well as mentoring you will have fully line managed your team and have had a solid career background as a CRA preferably with cardiovascular Treatment therapeutic experience .You will be office based in central London , you must already have the right to live and work in UK.

Key Responsibilities:

* Provide management to the CRAs to ensure that their role and contribution is optimised: providing feedback, setting clear tasks and objectives and coaching team members on a regular basis
* Manage and assess/mitigate risks and help plan timelines for deliverables
* Mentor, train and contribute to the development of junior CRAs
* Ensure CRAs organise and conduct study site initiation meetings
* Setting up systems/trackers and SOP's to support CRA activities to monitor progress of site and countries.
* SOP writing
* Serve as primary communication/escalation point for RPMs and CPMs
* Oversee tracking of completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
* Responsible for planning and delivery of successful Ethics committee submissions including preparation of trial related documentation (site contracts, letters of agreement, confidentiality agreements) where relevant.
* Setting up and monitoring the systems whereby the CRAs can manage patient recruitment strategies to increase patient accrual into studies (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
* Review monitoring reports and provide coaching to CRAs as needed to ensure compliance with protocol and GCP requirements

* Comply with all applicable laws / regulations of each country in which we do business
* Demonstrate high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians
* Report legal, compliance and ethical violations in a timely manner
* Develops and maintaining collaborative relationships with investigational sites

Must Have Skills and Experience:

* Proven clinical trials management and leadership experience
* Experience developing and managing your team FULLY including Apraisals,
* Life science or other relevant degree
* Excellent organisational skills
* Flexible and effective project management, communication and negotiation skills
* Ideally a strong understanding of cardio vascular disease and treatment
* Proven analytical thinking and decision making skills
* Strong and proven customer engagement

Candidates MUST have current and valid eligibility to work in the UK in order to be considered for this role.

Pop Science are an innovative, personal and experienced recruitment and staffing consultancy. Our aim is to make science more popular by championing careers in clinical and scientific research, technology, engineering, maths and more. Whether you want a permanent job, a contract role or even a change in perspective with some volunteering, contact us and let us help you. We support working practises that promote happiness at work.

We're an experienced, skilled team with personality; we have a passion for science, and drive and enthusiasm to make a difference to you.

Find out more at Pop Science - Recruitment