Clinical Research Associate/senior Clinical - London, United Kingdom - MSD

MSD

Verified Company

London, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

We are a research-driven biopharmaceutical company.

Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world.

We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are looking for a Clinical Research Associate or Senior Clinical Research Associate, who, with support from the Clinical Research Associate Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

This is a field-based role.

Responsibilities:

Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs clinical study site management and monitoring activities in compliance with International Conference on Harmonisation
Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gains an indepth understanding of the study protocol and related procedures.
Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participates and provides inputs on site selection and validation activities.
Performs remote and onsite monitoring and oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased.
Subjects' right, safety and wellbeing are protected.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive and accurate visit and nonvisit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study startup, study maintenance and study closeout.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits and inspections and overall site performance.
Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined Clinical Research Associate's Escalation Pathway.
Manages and maintains information and documentation to timelines.

Qualifications, Experience and Skills:

A degree in science or science related degree.
Clinical research experience. Related Clinical Research experience may include Clinical Trial Assistant, Study Coordinator or similar.
Fluent in English and excellent communication skills, including the ability to understand technical information. Developing the ability to present technical information with support.
Good understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonisation
Good Clinical Practice and country clinical research law and guidelines.
Good understanding of Global, Country and Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices
Developing skills in Site Management including management of site performance and patient recruitment
Developing level of monitoring skill and independent professional judgment.
Effective time management, organizational and interpersonal skills.
Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
Sense of accountability and urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager
Works effectively in a matrix multicultural environment. Ability to establish and maintain working relationships.
Excellent Customer focus and engagement.
Ability to travel domestically and internationally approximately around 65%75% of working time. Expected travelling is around 23 days per week.
Current driver's license.

Clinical Research Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.

Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

THE COMPANY
Our presence in the UK goes back a long way.

For over 80 years, we've been researching, developing and supplying new medicines and vaccines that prevent and treat diseases that occur at every stage of life.

Today we're one of the top five biopharmaceutical companies in the UK and employ over 2,000 people across five sites in Hertfordshire, Northumberland, Buckinghamshire, Edinburgh and London.

We are officially certified by the Top Employer Institute and been awarded the exclusive Top Employer United Kingdom Certification.

WHO WE ARE
We are kno