Lab Project Associate II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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:

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. Maintains the sample processing unit.

Essential

Functions

• 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.

• Note: Some tasks listed above only to be conducted as per country regulations

and with relevant valid qualifications/ certification or supervision.

Qualifications:

Education and Experience:

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.

Knowledge, Skills and Abilities:

• 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

Working Conditions and Environment:

• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.

Physical Requirements:

• 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