inVentiv Health Clinical Research Associate II/Senior CRA , UK in United Kingdom

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 II/Senior CRA , UK

Job ID 15887

Job Status Full Time Regular

Position Overview As a key member of our Clinical Monitoring team you will be responsible for all clinical monitoring activities following study guidelines, SOPs, and applicable regulations. Travel will be across the country with a maximum expectation of eight days on site per month, supported by a local Line Manager and with excellent opportunity for career development inVentiv Health really can offer you a CRA role with a difference.

Responsibilities Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements

Mentor CRAs on monitoring, internal procedures, and query resolution

Use expertise and judgement to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training

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 staff

Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff

Interpret data to identify protocol deviations or major risks to data integrity

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 and identify and address any protocol deviations and make appropriate recommendations

Generate queries and manage resolutions with site staff

Maintain project tracking systems as required

Participate in the identification and selection of investigators and clinical sites

Assist in the development of study specific monitoring procedures and guidelines

Mentor 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

Requirements Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

Prior clinical monitoring experience

Knowledge of Good Clinical Practice/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

Branch/Location Office Home or Office

Country United Kingdom [UK]

Broadcast Company Name inVentiv Health Clinical

Compensation & Benefits Overview Competitive remuneration package with excellent benefits

Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization

Opportunity to work within a successful and rewarding environment