Senior CRA

🕒 October 13

🇿🇦 South Africa – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage sponsor procedures, guidelines, and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to identify site-process failures and corrective/preventive actions • Ensure data accuracy through source data review, source data verification, and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical study systems, including CTMS, and perform quality-control checks of CTMS reports • Participate in investigator meetings and identify potential investigators with client companies • Initiate clinical trial sites and make recommendations regarding site acceptability • Ensure trial closeout and retrieval of trial materials • Maintain essential documents and conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls • Facilitate communication among investigative sites, client companies, and the project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to project work and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • 2+ years of experience as a clinical research monitor or comparable experience • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Effective clinical monitoring skills • Understanding of medical/therapeutic areas and medical terminology • Understanding and application of ICH GCPs, applicable regulations, and procedural documents • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills • Ability to communicate with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Interpersonal, organizational, and time management skills • Flexibility and adaptability • Ability to work independently and in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with sponsor/client/site requirements, including possible vaccination-status or personal-information disclosure requirements • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work in office, laboratory, clinical, and/or home-office environments • Ability to use required personal protective equipment

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Opportunity to work with a global team • Exposure to projects supporting leading pharmaceutical companies and biotechs • Professional collaboration and project team participation • Potential travel and extended overnight stays associated with site monitoring

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