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About the Role
Ensures timely and accurate completion of day-to-day laboratory work. Performs a wide variety of low, moderate and high complexity clinical laboratory testing within a variety of studies over various therapeutic areas. Responsible for maintenance of the equipment and sample processing unit.
Responsibilities
- Performs clinical laboratory testing on samples according to established laboratory procedures and verifies/reports test results as requested by study protocol.
- Performs a wide variety of testing, including but not limited to serology-based testing, pregnancy testing, urinalysis, KOH prep and TV rapid testing.
- Utilizes department protocols to undertake procedures to a consistently high standard.
- Accurately performs quality control/assurance and proficiency testing as needed.
- Uses the equipment as per the operating procedures monitoring and reporting faults to the relevant personnel.
- Ensures control of the laboratory environment, safety specifications and the maintenance and calibration of laboratory material required to conduct clinical trials.
- Maintains accurate freezer logs, temperature monitoring logs, specimen labelling and documentation.
- Assists with sample shipment (packing, documentation, organization with courier) and ensures the good quality of the shipment.
- Maintains confidentiality in relation to all information regarding patients.
- Provides support and reassurance to patients, taking into account their physical and psychological needs.
- Ensures quality at the site, adherence to ICH/GCP, SA GCP guidelines, GCLP guidelines and LQMP and adherence to COP’s, SOP’s.
Requirements
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Technical positions may require a certificate
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- Good medical terminology and ability to perform conducting of vital signs
- Strong understanding of quality compliance and Good Clinical Practices (GCP), with ability to learn and maintain a good working knowledge of FDA regulations and company/client SOPs and WPDs
- Basic computer skills, including proficiency with Microsoft Office, and capable of learning new software/hardware
- Good attention to detail
- Good problem-solving abilities
- Good organizational and time management skills with the ability to multitask and oversee numerous studies with a variety of therapeutic areas and sizes simultaneously
- Strong oral and written communication skills, including the use of Business English
- Skilled in all types of audit preparations and oversight during audits
- Good interpersonal, leadership and consultative skills
- Familiarity with archival processes and systems
- Able to lift 40 lbs. without assistance
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
- Will work with hazardous/toxic materials
- Frequently stationary for 4-6 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Skills
- Medical terminology
- Conducting of vital signs
- Quality compliance
- Good Clinical Practices (GCP)
- FDA regulations
- Company/client SOPs and WPDs
- Microsoft Office
- Attention to detail
- Problem-solving
- Organizational skills
- Time management
- Multitasking
- Oral communication
- Written communication
- Business English
- Audit preparations
- Audit oversight
- Interpersonal skills
- Leadership skills
- Consultative skills
- Archival processes
- Archival systems
Location
- Office
Work Type
- Standard (Mon-Fri)
- Office
- Full-time
Experience Level
- At least 4 years
Education Level
- High / Secondary school diploma or equivalent
- Relevant formal academic / vocational qualification
- Certificate (for technical positions)
About the Company
- At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale.
- Our Mission: 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.