Clinical Research Associate
Jobbeschreibung
Zug, Zug, Schweiz
AbbVie
27.04.2024
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DescriptionWe are a global, research-based biopharmaceutical company
focused on the discovery and development of innovative treatments that
address some of the world’s most serious and complex diseases. We
strive to have a remarkable impact on people’s lives across several
key therapeutic areas: immunology, oncology, neuroscience, eye care,
virology and gastroenterology. In addition, AbbVie offers products and
services through its Allergan Aesthetics portfolio.AbbVie with
headquarters in Chicago, USA, employs approximately 50,000 employees
worldwide and is celebrating its 10th anniversary in 2023. Around 57
million patients in more than 175 countries benefit from AbbVie
medications annually. Approximately 250 employees are employed in
Switzerland and the AbbVie Switzerland headquarters are located in
Cham, ZG. For more information, visit our website: To enable AbbVie’ s
emergence as a world class R&D organization, the position anticipates
and proactively solves study related clinical site issues as they
occur and initiates, recommends and communicates corrective action
ensuring successful protocol level execution of CSM deliverables
involving startup, execution, and closeout of studies. KEY
RESPONSIBILITIES: Monitors activities conducted by clinical
investigative sites as they relate to AbbVie clinical studies to
ensure successful execution of the protocol. Ensures adherence to
federal regulations and applicable local regulations, Good Clinical
Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures
(SOPs), Monitoring Plans, and to quality standards in conducting
clinical research. Conducts site qualification, initiation, interim
monitoring and study closeout visits for Phase I-IV studies in
accordance with applicable regulations, Good Clinical Practices
(GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures
(SOPs) and business processes. Overviews the overall activities of
site personnel over whom there is no direct authority and
motivates/influences them to meet study objectives. Proactively
manages the site and ensures action plans are put into place as needed
to ensure compliance. Ensures regulatory inspection readiness at
assigned clinical sites. Ensures quality of data submitted from study
sites and assures timely submission of data, including appropriate
reporting and follow-up for all safety events by site personnel.
Ensures safety and protection of study subjects through compliance
with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and
applicable regulations. Trains study site personnel on the protocol
and applicable regulatory requirements in collaboration with pertinent
project team members. Manages investigator payments as per executed
contract obligations. Negotiates investigator/ hospital agreements
with stakeholders. Maintain and complete own expense reports as per
local and applicable guidelines. Identifies, evaluates and recommends
new/potential investigators/sites on an ongoing basis. Potential sites
may be identified through networking or internal AbbVie requests to
assist in the placement of planned clinical studies with qualified
investigators. QualificationsQUALIFICATIONS AND EXPERIENCE:
Appropriate tertiary qualification, health related (e.g., Medical,
Scientific, Nursing) preferred. Minimum of 1 year of clinically
related experience, of which a period of 6 months is preferable in
clinical research monitoring. Experience in onsite monitoring of
investigational drug or device trials is required Fluency in German
and EnglishCurrent Indepth knowledge and understanding of appropriate
therapeutic indications as they relate to the conduct of clinical
trials. Current Indepth knowledge of regulations governing clinical
research, ICH/GCP Guidelines and applicable regulations. CRITICAL
SKILLS REQUIRED FOR THE ROLE: Strong planning and organizational
skills and the ability to work effectively and efficiently in a
dynamic environment with competing projects and deadlines. Ability to
work, understand and follow work processes within the assigned
function. Strong analytical and conceptual capabilities, interpersonal
skills, and ability to communicate with clarity. Ability to address
study related clinical site issues with appropriate guidance and
initiates and communicate corrective action as indicated. Ability to
use functional expertise and exercise good judgment. Demonstrated
business ethics and integrity. AbbVie is not accepting unsolicited
assistance from search firms for this employment opportunity. Please,
no phone calls or emails. All resumes submitted by search firms to
any employee at AbbVie via email, the Internet or in any form and/or
method without a valid written search agreement in place for this
position will be deemed the sole property of AbbVie. No fee will be
paid in the event the candidate is hired by AbbVie as a result of the
referral or through other means.Job Field: Clinical ResearchJob Type:
ExperiencedOrganization: Research & DevelopmentSchedule:
Full-timeTravel: No