Sr CRA (Level II) at Thermo Fisher Scientific

Taipei, Taiwan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Bachelor's degree in a life sciences related field or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor)
Valid driver’s license where applicable
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience
Effective clinical monitoring skills
Proven understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including critical approach, in-depth investigation for appropriate root cause analysis and problem solving
Ability to handle Risk Based Monitoring concepts and processes
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills

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
Conducts monitoring tasks in accordance with the approved monitoring plan and documents observations in reports and letters in a timely manner
Raises 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 identified issues are being resolved and that the data is being recorded
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS)
Performs QC check of reports generated from CTMS system where required
Participates in investigator meetings
Initiates clinical trial sites to ensure compliance
Performs trial close out and retrieval of trial materials
Conducts on-site file reviews
Facilitates effective communication between investigative sites, the client company and the internal 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
May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members

Skills

Clinical Monitoring

Site Management

ICH-GCP

Risk-Based Monitoring

Root Cause Analysis

SDV

SDR

CRF Review

CTMS

Protocol Compliance

Regulatory Compliance

Investigator Meetings

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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