AbbVie Clinical Research Associate in Songpa-gu, South Korea
Clinical Research Associate
South Korea, Seoul, Songpa-gu
1 additional location
South Korea, Seoul
Research & Development
Requisition # 1904418
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 1-4 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 on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
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 on-site monitoring of investigational drug or device trials is required
Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
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.
* 애브비는 개인정보 보호법과 채용 절차의 공정화에 관한 법률를 준수합니다 . 보내주신 이력서는 채용하는 포지션에 대한 채용 검토 목적으로만 사용되며 사용 목적이 다한 즉시 폐기 합니다 .
Travel: Yes, 25 % of the Time
Job Type: Experienced
Equal Employment Opportunity Employer
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.