Cra

hace 2 semanas


Bogota, Colombia Thermo Fisher Scientific A tiempo completo

**Qualifications**:
Education and Experience:
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and
relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1
years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
Valid driver's license where applicable.

**Essential Functions and Other Job Information**:

- 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 in a timely manner using
- approved business writing standards. Escalates observed deficiencies and issues
- to clinical management expeditiously and follow all issues through to resolution.
- May need to maintain regular contact between monitoring visits with
- investigative sites to confirm that the protocol is being followed, that previously
- identified issues are being resolved and that the data is being recorded in a
- timely manner. Conducts monitoring tasks in accordance with the approved
- monitoring plan. 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 as necessary. Identifies potential

investigators in collaboration with the client company 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 essential 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.- Contributes to the project team by assisting in preparation of project

publications/tools, and sharing ideas/suggestions with team members.- Contributes to other project work and initiatives for process improvement, as

required.


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