Clinical Research Associate/ Sr CRA

Overview: TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions (SRS) team and we are looking for an experienced, highly motivated Clinical Research Associate who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.
Together we make a difference.
TFS HealthScience is looking for a Clinical Research Associate/ Senior CRA to be home based in the United Kingdom.
This is a permanent position with focus on career progression and dedicated to one of our biggest prestigious pharmaceutical clients!
We look forward to receiving your application soon!
What can we offer you? A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. UK benefits include:

• Private Health Coverage
• BUPA CrashPlan
• Corporate Pension Plan
• Life Insurance
• Global General Liability Insurance
• Global Travel Insurance
• Homebased Allowance for home-based employees
• Car Allowance
• Flexible working schedule

Responsibilities:

• Obtain and maintain essential documentation in compliance with ICH-GCP, TFS procedural documents and local regulations both in trial master file (TMF) and investigator study file (ISF).
• Actively participate in local study team meetings.
• Contribute to the selection of potential investigators.
• Train, support and advise investigators and site staff in study related matters.
• Contribute to national investigators meetings.
• Initiate, monitor and close study sites in compliance with TFS procedural documents. Share information on patient recruitment and study site progress within local study team.
• Drive performance at the sites. Proactively identify study-related issues, solutions and escalate as appropriate.
• Update CTMS and other systems with data from centers as per required timelines.
• Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
• Perform source data verification according to SDV plan.
• Oversee data query resolution by the site.
• Verify accurate and timely reporting of serious adverse events.
• Prepare for activities associated with audits and regulatory inspections in liaison with local study delivery team lead and CQM.
• Provide the required monitoring visit reports within required timelines.
• Support and work together with lead CRA, LSM and regulatory affairs to see to timely delivery of study documents for submissions to RA and EC.
• Contribute to financial agreements with relevant staff at investigational site in collaboration with lead CRA and/or LSM.
• Oversee timely preparation of country specific CSA in collaboration with LSM and/or lead CRA.
• Verify compliance with TFS’s code of conduct and company policies and procedures relating to people, finance, technology, security and safety, health and environment.
• Track and manage agreed payments at study site level.
• Participate in training and mentoring of new members of the local study team verifying compliance with ICH/GCP and TFS procedural documents.

Qualifications:

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• Previous experience as CRA including relevant independent on-site monitoring
• Study experience in any of the following therapeutics areas: Oncology, Cardiovascular, Renal and Metabolism, Respiratory or Immunology.
• Able to work in a fast paced environment with changing priorities
• Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
• Possess the understanding of Good Clinical Practice regulations, ICH guidelines
• Ability to work independently as well as in a team matrix organization
• Excellent written and verbal communication skills
• Excellent organizational skills
• Open for possibility for national travel

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TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.