Shire Jobs

Mobile Shire Logo

Job Information

DOCS Senior Clinical Research Associate - Oncology *Southern England* home-based in London, United Kingdom

Senior Clinical Research Associate - Oncology Southern England home-based

Ref #: 24714

Employment type: Permanent - Full-Time

Location: South England

Posted: 18-Oct-2020

Description

Here at DOCS Global, we've entered into a partnership to supply an additional full-time, permanent home-based Independent Oncology CRAs to be aligned with a top-10 multinational pharmaceutical and biopharmaceutical company.

Your focus will be the management of Oncology Clinical Trials on a monitoring basis.

You will need to be well-versed in the role of an Independent CRA, including experience of independent monitoring visits, SIVs and Close-Out Visits.

Ideally, you need to be based in Southern England, where the sites will be based.

What is Offered;

  • Excellent Salary package

  • Permanent career opportunity, including extensive training period.

  • Home-based flexibility

The Role and your Responsibilities;

• To perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.

• Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);

• Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the PM;

• Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;

• Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports;

• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;

• Communicates effectively with site personnel, including the Principal Investigator (PI), and company management to relay protocol/study deviations and ensure timely implementation of corrective actions;

What is Required;

• Degree (BA/BS/BSc) in life sciences or qualified nurse preferable

• At least 12/18 months CRA experience gained within the industry as a Clinical Research Associate (CRA) either in Clinical Research Organisation (CRO) or pharmaceutical industry or investigational site

• Experience of clinical trial set up and contract negotiation preferred, but not essential

• EDC working experience

• Full-time availability

Contact dominic.brady@docsglobal.com/+447584558534 to discuss in more detail.

#CRAjob

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

DirectEmployers