Fsp Sr Cra

hace 7 días

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

**Summarized Purpose**

**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 products 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
- Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM).
- 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.
- Ensures 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.
- Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members.
- Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements & shares potential solutions for improvements.
- Performs additional tasks as assigned by CTM or Clinical Manager of CRAs (CM-CRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).
- 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, CTMS). Perform QC check of reports generated from CTMS system where required.
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections federal regulatory requirements/audits.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Job Complexity Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Job Knowledge Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
- Supervision Received Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Business Relationships Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters.
- Builds productive internal / external working relationships.

**Education and Experience**:

- Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualifica

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