该职位来源于猎聘 Key responsibilities:
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters using approved business writing standards. May need to maintain regular contact between monitoring visits with investigative sites to check if the protocol is being followed. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
- Participates in investigator meetings. Identifies potential investigators to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
- Ensures that required documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
- Assisting in other project work and initiatives for process improvement, as required. Keys to Success: Education
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or relevant formal academic / vocational qualification. Experience
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) Knowledge, Skills, Abilities
- Validated clinical monitoring skills
- Validated understanding of medical/therapeutic area knowledge and medical terminology
- Ability to attain and maintain an understanding of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills
- Ability to handle Risk Based Monitoring concepts and processes
- Good oral and written communication skills
- Ability to remain flexible and adaptable in a wide range of scenarios
- Ability to work in a team or independently as require
- Good English language and grammar skills
- Good presentation skills