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France Keyrus Biopharma

Clinical Research Associate Senior (M/F)

Job Description

Main tasks:

-Participation in the creation of the monitoring documents (monitoring guidelines, tracking tools, working documents…),

-Participation in the regulatory submissions (Competent Authorities and Ethics Committee),

-Site management: feasibility, selection, initiation, monitoring on site + remote and close-out,

-Serious Adverse Event (SAE) declaration and follow-up,

-On site data entry activities,

-Management of study drugs: drug accountability, returns, storage conditions, resupplies requests…

-Management of the study material,

-Management of study documents: TMF, investigator site file, essential documents collection,

-Study tracking and follow up tools update,

-Case report forms quality control and handling,

-Management of queries,

-Communication with the investigational sites,

-Investigators and hospitals contracts management,

-Management of investigator fees and hospital invoices,

-Participation in investigator’s meeting,

-Support Project Managers on any clinical studies activities: eg monitoring report review…

-Organisation of co monitoring visits

-Respect of quality commitments,

-Participating in the improvement of the Quality System : non-conformities management, review/creation of standard procedures and documents,

-Potential numerous business travels,

-Proactive force

-Take on any other task as assigned by the line Manager

Profile

Required skills and qualities and expected level:

-High level of autonomy in his/her job

-High level of English (spoken and written)

-Knowledge of GCP and ICH Guidelines

-Good command of office software (excel, word, power point)

-Analytical, rigorous and organized

-Good interpersonal skills

-Good oral and written communication

-Ability to summarize

-Problem Solving – Can assimilate information and ideas from a wide source to make high quality decisions. Takes a broad overview of the situation / problem or event.

Required level of education:

-Scientific diploma 3-4 years diploma minimum completed with previous experience as CRA

Who we are

A major European player in clinical research, Keyrus Biopharma is a CRO (Contract research Organisation) created in 1998, which has 310 employees spread over 6 sites in France (Paris, Nantes and Lyon) and abroad (Belgium, Tunisia and Canada). Keyrus Biopharma has directed its development strategy on innovation and creativity to offer its customers solutions with high added value. We specialize in all areas of clinical studies services: Regulatory submissions, feasibility studies, implementation and monitoring, data management, bio-statistics and medical writing. We intervene in the different phases of development, clinical phases I to IV, epidemiology and investigations. To date, Keyrus Biopharma provides expertise and consultancy in all areas of clinical research based on its experience and has been able to adapt to the requirements of new environment/sectors such as nutrition, biotechnology, Cosmetology and medical devices.

Publication date

16.01.2019