- Contributes to the selection of potential investigators.
- In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
- Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
- Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
- Actively participates in Local Study Team (LST) meetings.
- Contributes to National Investigators meetings, as applicable.
- Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
- Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
- Updates CTMS and other systems with data from study sites as per required timelines.
- Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
- Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits.
- Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
- Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
- Ensures data query resolution in a timely manner.
- Works with data management to ensure robust quality of the collected study data.
- Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
- Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP.
- Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
- Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
- Assists site in maintaining inspection ready ISF.
- Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM.
- Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM or delegate.
- Ensures that all study documents under their responsibility (i.e. site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF.
- Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
- Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Ensures compliance with local, national and regional legislation, as applicable.
- Collaborates with local MSLs as directed by LSM or line manager.
Minimum Requirements and Preferred Background
- University degree in related discipline, preferably in life science, or equivalent qualification.
- Fluent knowledge of spoken and written English.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge in relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Ability to travel nationally as required.
Competencies and Skills
- Ability to deliver quality according to the requested standards.
- Ability to work in an environment of remote collaborators.
- Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
- Good analytical and problem solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Good cultural awareness.
- Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
[근무조건 및 환경]
Direct contractor - Entry (신입, 직접계약직, 이후 정규직 전환 검토)
Contract period could be max. 2 years. Changing position could be considered after 2 years in current position
선택적 근로시간제 (Core-time제) 정규직과 동일한 복리후생 제공
[ 자격요건 ]
신입계약직 및 정규직: 약학 / 제약학 / 생명과학
공학 / 유전공학 / 화학 / 생물학 학사학위 이상 취득자
해외여행의 결격사유가 없는 분
남자의 경우 병역 필 / 면제인 분
국어 / 영어 의사소통이 능통한 분
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.