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Job Details

SENIOR CLINICAL RESEARCH ASSOCIATE

Company: Chiltern
Location: Anywhere in UK but ideally near London!
Reference: MLJAUTOCRA
Closing Date: 19 Nov 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

We have an incredibly exciting CRA vacancy – ideally based around the London/Greater London area BUT we will consider SCRAs anywhere in the UK, as long as for the first few weeks you are happy to be down in the London office a few days each week for training and inductions etc.

Requirements:

Job Background

Our Client is a small company specialising in T Cell Therapy for solid tumour and blood cancer. They are currently embarking on a series of Phase I and Phase II studies – all falling under one protocol. Sites are currently being set up in the UK and some sites are already up and running.

The results shown by initial studies are astonishing and for someone who has a leaning towards the Oncology area this role offers amazing job satisfaction and top-notch career development potential further down the line. Their office is near Shepherds Bush in West London but the role can be field based.

You will ideally have Phase I/II experience and of course Oncology (ideally haematology) experience is a must for this role.

You will be a SENIOR CRA.

The role will involve full site management and INTENSE monitoring during these early phase studies.

The role will include feasibility and site relationship management (very important).

Site visits will average at around one to two days/week at the start reducing to a few days per month once the studies are up and running. ALL sites are UK based.

We are ideally looking for people who are willing to be employed by Chiltern on PAYE salary and benefits - VERY COMPETITIVE salary .........BUT we may consider freelance CRAs AS A LAST RESORT - if you are an ideal match and have the appropriate level of experience. In either case there are EXCELLENT long term career prospects as the company expands it's monitoring activities and moves into phase II and beyond.

We may even consider someone 4 days/week if you meet the criteria above.

The most important thing is that we find someone who can HIT THE GROUND RUNNING on these complex Oncology studies within early phase. We want “old school” SCRAs – we would want to see LONGEVITY and COMMITMENT on the CV as the company requires “stayers” as opposed to “jumpers”! To EMPHASISE – we really would prefer to look at EMPLOYEES and will only consisder freelancers as a very last resort.

You will join a small but growing Clinical Operations team responsible for the performance of trial sites in the UK and EU countries in compliance with Good Clinical Practice (GCP), ICH guidelines and EU/FDA regulations. This includes site qualification, initiation, monitoring and closeout. Key Responsibilities

Providing oversight of the entire site management process for the life cycle of the trial sites, eTMF management, development and maintenance of trial documents, including logs and tracking of site performance metrics

Ensuring site qualification (pre-study), initiation, monitoring and study closeout visits are conducted in accordance with US federal regulations, Good Clinical Practices, ICH Guidelines, and Standard Operating Procedures and business processes

Monitoring activities of assigned sites and as primary liaison for all clinical monitoring issues, escalating as appropriate to Project Manager and / or Functional Manager in accordance with relevant study plans and Standard Operating Procedures and business processes

Assist sites and internal staff with preparation for GCP audits, including file review according to the clinical project plan 

Reviewing and entering all protocol deviations in collaboration with other CRAs and escalating as required

Developing and maintaining a country recruitment / retention strategy in collaboration with the Clinical Project Manager (CPM)

Identifying potential risks to the enrolment targets based on feasibility and recruitment updates in collaboration with the CPM

Attending, participating and presenting at Investigator meetings as needed

Supporting the Data Manager, Pharmacovigilance Manager and Medical Monitor in communicating and resolving issues and obtaining follow-up information

To travel to UK/European sites on a regular basis as required

Any other duties as required following consultation with the post holder

The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company

Preferred Experience • Minimum of 5 years’ experience in running clinical trials, ideally within pharmaceutical, biotechnology or CRO and / or healthcare setting, of which 3 years must be where the previous roles were directly related to the management of site performance in accordance with clinical trial execution

Minimum of 3 years of site monitoring experience required

Monitoring experience in Oncology, particularly early phase is preferred

Experienced in managing a varied and complex workload

Monitoring experience of cellular therapies or relevant experience will be given special consideration

Qualifications

Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification

Skills/Specialist knowledge

Thorough knowledge of ICH, GCP, CFR and EU Directives, including ATMP and how these relate to trial management

Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan

Experienced in building relationships with current and potential investigators

Demonstrable computer skills (MS Office, MS Project, PowerPoint)

Ability to travel as required

French, Spanish or German language at a level sufficient to monitor in those countries an advantage, other EU languages may also beneficial - P

Salary

On Application

Position Type

Permanent or Contract
Full Time

Contact

Email Marc Joseph - Marc.Joseph@chiltern.com
+44 (0) 1753 216 664

Apply for this job: SENIOR CLINICAL RESEARCH ASSOCIATE

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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