Lab Project Associate II

Thermo Fisher Scientific•Austin, TX

5d•Onsite

About The Position

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.

Requirements

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).
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

Nice To Haves

Technical positions may require a certificate
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.

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.