DOCS Global

CRA I/II - Oncology North-West or Scotland

Location
Northern , UK
Salary
Competitive
Posted
09 Feb 2021
Closes
11 Mar 2021
Ref
26802
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Our client requests suitable Commercial Industry candidates with extensive Oncology experience, happy to travel to and manage sites located in the North-West and Scotland regions.

Whilst you do not need to be operating in a CRA capacity today, it would be advantageous. You will be operating in an experienced team, and a supportive environment to help you grow into the CRA role.

POSITION SUMMARY

Primary point of contact between site staff and client. Acts as ambassador for the company and contributes to making our client the preferred partner.
• A Clinical Research Associate is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from study planning through data-base lock.
• Responsibilities include study planning, study start-up, study execution and study close-out. Delivers results that have direct impact on the successful completion of the study.
• Partner with the CTA and CSM to ensure overall site management while performing study related activities for assigned protocols.
• May contribute to process improvement, training and mentoring of other Clinical Research Associates.

JOB FUNCTIONS/RESPONSIBILITIES

Study Planning
? Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
? Assume ambassadorial role to facilitate communication between sites and the client CPO to increase value proposition to investigators.
? Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
? Negotiate investigator remuneration; prepare financial contracts between the client and investigational sites and investigators. Ensure adherence to payment schedule.

Study Start-up
? Execute site initiation and training, generate initiation visit report.

Study Execution
? Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
? Identify problems at sites; resolve issues and escalate as appropriate.
? Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
? Complete preparation and generation of visit monitoring reports as per relevant SOP
? Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
? If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues

Study Close-out
? Implement site close-out activities and generate site close-out report.
? Provide feedback on site performance for future trial site feasibility/selection

General
? Improve skills by timely completion performance of assigned global and local training.

EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
? Must have experience in Clinical Research or equivalent qualification
? Minimum 2 - 4 years prior monitoring experience with global trials.
? Specific therapeutic area experience may be required depending on the position.
? Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and
regulations, assigned protocols and associated protocol specific procedures including monitoring
guidelines.
? Ability to build and maintain relationships with sites
? Responsible and accountable
? Excellent communication and negotiation skills
? High focus on delivery and quality
? Ability and willingness to adjust quickly to new situations in a continuously developing
environment
? Strong IT skills in appropriate software and company systems.
? Willingness to travel with occasional overnight stay away from home.
? Proficient in speaking and writing the country language and English. Good written and oral
Communication skills.
? Excellent self-organizational and time management skills are required. Attention to detail is essential.
? Good intercultural understanding.

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