stillingsbetegnelse: Experienced CRA (m/f) - 1418443

jobbeskrivelse:
Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more please visit quintiles.com. PURPOSE Conduct monitoring visits for assigned protocols and study sites. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements RESPONSIBILITIES • Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. • Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness. • Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. • May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval. • May perform assigned administrative tasks to support team members with clinical trial execution. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines • Good therapeutic and protocol knowledge as provided in company training • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer • Good written and verbal communication skills including good command of English language • Good organizational and problem-solving skills • Effective time management skills • Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Bachelor's degree in a health care or other scientific discipline or educational equivalent, and successful completion of a CRA Trainee Program or 3+ months of on-site monitoring experience; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS • Extensive use of telephone and face-to-face communication requiring accurate perception of speech • Extensive use of keyboard requiring repetitive motion of fingers • Regular sitting for extended periods of time • Frequent travel to sites, primarily domestic, may include international travel For applying please go to: https://quintiles.taleo.net/careersection/10000/jobdetail.ftl

Arbejdsgiver Navn: QUINTILES, FILIAL AF QUINTILES AB

Arbejdsgiver telefonnummer: 33938401

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark