inVentiv Health Clinical Research Associate (CRA) - Singapore in Singapore, Singapore
Organization Overview inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients’ therapies to market
Title Clinical Research Associate (CRA) - Singapore
Job ID 13030
Position Overview Successful applicant will be working in our global sponsor's office
The Clinical Research Associate II will perform clinical monitoring activities following study guidelines, SOPs, and applicable regulations. This position is responsible for ensuring the overall integrity of assigned studies through the use of independent judgment to assess adherence to study protocol and regulations.
· Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements.
· Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations.
· Evaluate overall performance of site and site staff.
· Ensure compliance and understanding of study requirements by site contacts.
· Apply judgment and knowledge to independently resolve site issues
· Interpret data to identify protocol deviations or major risks to data integrity.
· Provide recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff
· Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines.
· Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
· Review and verify case report forms and other clinical data for completeness and accuracy.
· Monitor patient safety, identify and address any protocol deviations.
· Generate queries and manage resolutions with site personnel.
· Participate in the identification and selection of investigators and clinical sites.
· Maintain project tracking systems as required.
· Work with junior staff on training, guidelines, and processes.
· Complete assigned training programs and apply learning.
· Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations.
· Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
· Two to three years prior clinical monitoring experience
· Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements
· Strong organizational skills
· Must demonstrate good computer skills.
· Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
· Ability to travel
Country Singapore [SG]