The Clinical Trials Associate (CRA) is to assure the implementation of study plans, to be in charge of Ethics committee and Competent authority regulatory submissions of clinical study applications. The CRA performs site administration and site monitoring for clinical studies according to Sponsor or Q-Trials Standard Operating Procedures, ICH Guidelines and GCP, clinical protocol and local regulations.The CRA is also responsible for clinical studies according to Sponsor or Q-Trials Standard Operating Procedures, ICH Guidelines and GCP and local regulations.
Primary duties and responsibilities:
Manage small to large scale studies according to protocol and study plans and in light of GCP, applicable SOPs and the local regulations.
Write clinical study reports.
Perform feasibility work and assessment of potential investigators, pre-study visits as required
Responsible for all aspects of study site monitoring and regulatory tasks:
Doing EC submissions and notifications to regulatory authorities, translation of study-related documentation.
Perform Site initiation, Routine monitoring and Close-out of clinical sites, maintenance of study files, review investigational product conditions.
Responsible for all aspects of site management as described in the study plan/manual
Liaise with vendors, act as contact point for clinical study supplies and other suppliers (vendors) as applicable.
Updates trackers and maintains study-specific trial management tools and systems.
Attend investigators’ meetings, project team meetings and teleconferences accordingly.
Manage investigators’ payments and other study financial matters as required.
Perform other duties as assigned by management.
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing
Clinical research experience in pharmaceutical or CRO industries will be considered.
CRA course graduate.
Thorough knowledge of ICH Guidelines and GCP including excellent understanding of regulatory requirements and local regulatory requirements.
Knowledge of the drug development process.
Fluent in Hebrew and English, written and verbal.
Experience and skills:
Excellent learning ability
Excellent communication and interpersonal relations
Excellent client servicing skills
Relevant pre-entry experience can include, but is not limited to a background in medicine, nursing, pharmacy, medical sales, clinical laboratory work, clinical data work and academic or pharmaceutical research, clinical study work such as study coordination, clinical trials assistance
Confident and influential approach.
Ability to build effective relationships with site staff and colleagues.
Ability to motivate others.
Driven and focused
Individual whose intelligence together with expertise cause others to trust his/her work and problem solving capacity
Ability to self train, motivated to constantly up-date knowledge.
Eye for details.
Ability to multi-task.
Excellent planning and organization skills.
Excellent verbal and written communication skills.
Ability to resolve project-related problems and prioritize tasks.
Team player and independent enterpriser
Able to supervise study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCPs.
Maintains patient’s and sponsor’s confidentiality
Excellent computer skills including: Outlook, Word, Excel, PowerPoint and others
Available for travel up to 60% of the time, including overnight stays, if necessary, consistent with project needs and office location.
Ability to drive and have a valid driver’s license, own transportation to/from office.
Language Skills Required:
Speaking: English and Hebrew Writing/Reading: English and Hebrew