Clinical Research Associate II
P
Precision Medicine GroupClinical Research
Remote, ChinaFull-TimeMiddle
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- English
- Experience
- Minimum of 2 years of on-site monitoring experience; 1 year oncology trial experience preferred
- Required Skills
- Microsoft ExcelMicrosoft OfficePowerPoint
Requirements
- Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
- Minimum of 2 years of on-site monitoring experience
- 1 year oncology trial experience preferred
- High proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
- Customer service demeanour; demonstrate flexibility and teamwork.
- Ability to focus on detail for extended periods of time, high attention to accuracy.
- Fluency in English communication, verbally and in writing.
- Working knowledge of the drug development process.
- Travelling required (60-70%)
- Solid experience in clinical research or related experience.
- Excellent organizational skills.
- Ability to work efficiently in a remote work environment.
- Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
- Demonstrates solid interpersonal skills.
- Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
- Good written and verbal communication skills and presentation skills.
- Ability to deliver on commitments.
Responsibilities
- Oversees all aspects of study site management to ensure patient safety and data quality.
- Provides guidance at the site and project level towards audit readiness standards.
- Updates, tracks and maintains study specific trial management tools/systems, and status reports.
- Manages site start up procedures including feasibility, recruitment, EC/IRB submissions, and regulatory document collection.
- Assists the negotiation of study budgets and execution of investigator contracts.
- Verifies informed consent processes and assesses factors affecting subject safety and data integrity.
- Independently conducts all forms of site visits (pre-study, initiation, routine monitoring, close-out).
- Prepares and submits accurate and timely monitoring reports from all site visits.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs.
- Supports subject/patient recruitment, retention, and awareness strategies.
- Routinely reviews Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Communicates effectively and proactively with site personnel and Precision Project/Clinical Trial Management.
- Develops and maintains good working relationship with investigators and study staff.
- Performs investigational product (IP) inventory, reconciliation, and reviews storage/security.
- Performs data review activities, including remote EDC CRF and patient profiles review, query resolution.
- Identifies and processes Serious Adverse Events according to study team procedures.
- Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies.
- Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
- Participates in global clinical monitoring/project staff meetings and attends clinical training sessions.
- Travels as necessary according to project needs.
View Full Description & ApplyYou'll be redirected to the employer's site
