Senior Clinical Research Associate
Il y a 3 mois
TFS HealthScience is excited to be expanding our** **team and we are looking for an experienced, highly motivated **Clinical Research Associate** who shares our vision of providing clinical research excellence. Our CDS 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 core values of Trust, Quality, Flexibility and Passion are what make 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 **France.**
**What can we offer you?**
A great place to work where you will get the chance to push your career to the next level, a 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. France benefits include:
- Private Health Coverage
- Life Insurance
- Global General Liability Insurance
- Global Travel Insurance
- Homebased Allowance for home-based employees
- Lunch Allowance
- Flexible working schedule
**What We Offer**:
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
**Responsibilities**
- Obtain and maintain essential documentation in compliance with ICH-GCP, TFS procedural documents and local regulations both in the 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 the local study team.
- Drive performance at the sites. Proactively identify study-related issues, and solutions and escalate as appropriate.
- Update CTMS and other systems with data from centres 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 the local study delivery team lead and CQM.
- Provide the required monitoring visit reports within the 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 the investigational site in collaboration with the 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.
**Requirements**:
- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- Previous experience as CRA including relevant independent
on-site monitoring
- Study experience in Ophthalmology.
- 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 to the possibility of travel nationwide
- TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _privacy notice_ for further details._
- TFS HealthScience does not discriminate on the basis of race, sex, color, rel
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