inVentiv Health Clinical Research Associate II/Senior CRA , Sweden in Stockholm, Sweden

Organization Overview Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

Title Clinical Research Associate II/Senior CRA , Sweden

Job ID 15810

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 INC Research/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

City Stockholm

Country Sweden [SE]

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