Job Description
- Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
- Ensures the HGRAC and IRB submission and approval.
- Ensures assigned sites are conducting studies according to protocol requirements and applicable regulations and guidelines.
- Ensure that the rights and wellbeing of human subjects are protected.
- Ensure the trial data are accurate, complete, and verifiable from source documents.
- Verifies that the investigator is enrolling only eligible subjects.
- Performs verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data.
- Ensures that any corrections are appropriately documented by authorized site staff.
- Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
- Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
- Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
- Delivers quality written reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans.
- Ensure that the trial is conducted and documented properly from study start-up through close-out.
- Participates in site audits, as requested.
- May conduct site and study feasibility assessments.
- May be involved in the development of monitoring guideline and tools.
- Support study monitoring from other BU as needed.
Qualifications
- Bachelors or Masters Degree or University Degree or equivalent.
- At least 3 years CRA working experience in multinational pharmaceutical, Medical Device company or CRO.
- Have Medical Device or IVD clinical trials experience.
- Familiar with clinical trial Quality Management System.
- Good English skills, willing to learn, hard working.
- Candidate should be major in clinical medicine or pharmacy; Pathology would be a plus.
- 10% domestic travel.
Additional Details
This job has a full time weekly schedule.Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Travel Required:
10% of the Time
Shift:
Day
Duration:
No End Date
Job Function:
Medical/Clinical
