CRA (Level I) at Thermo Fisher Scientific

  • Published date: November 16, 2023
  • Category: Administrative & Office
    • Location: Nairobi, Nairobi
  • Jop type:
  • Salary: Ksh Not mentioned
  • Company name: Jobs in Kenya

Job Description

About the job

  • 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.

  • 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 tothe 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.

  • Job Complexity Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

  • Job Knowledge Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.

  • Supervision Received Normally receives detailed instructions on all work.

  • Business Relationships Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.


Method of Application

Interested and qualified? Go to Thermo Fisher Scientific on to apply


Share by email Share on Facebook Share on Twitter Share on Google+ Share on LinkedIn Pin on Pinterest

Apply Now

Related jobs

  • Program Specialist – Productive Use of Renewable Energy (PURE) at WRI
    Jobs in Kenya

    Job Highlight: You will report to Africa Lead for Energy Access Work. As the Programme Specialist – Productive Use of Renewable Energy (PURE), you will be part of the Energy Access for Equitable Development team. You will collaborate with other...

    November 16, 2023

    Ksh Not mentioned

    Apply Now

  • Data Officer - Health Electrification and Telecommunication Alliance (HETA) at Abt Associates
    Jobs in Kenya

    HETA is looking for a Data Officer to support its MEL Director by managing collection, capturing, data efficiently, conducting analysis, and ensuring data quality, integrity, and security which is essential for the success of HETA. Core Responsibilit...

    November 16, 2023

    Ksh Not mentioned

    Apply Now

  • Art Director at The Digital Monkeys
    Jobs in Kenya

    Role Description As an Art Director, you will be at the forefront of creating compelling narratives for our diverse clientele. Your role will be pivotal in ensuring that our creative output meets and exceeds our client's expectations and sets new sta...

    November 16, 2023

    Ksh Not mentioned

    Apply Now