Clinical Conduct

3 weeks ago

Doral, United States CareerBuilder Full time

Clinical Conduct - Clinical Laboratory Lead

Miami, FL, USA

Req #140
Thursday, March 28, 2024
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we helpbiotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development communitythats focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures,

fast. Because humanity needs solutions, fast.
The Role
Overall responsibility for quality of laboratory processing for assigned duties
To ensure study data is collected to a high quality in accordance with ICH-GCP, protocol and lab manual
To ensure subject safety at all times
Main tasks and responsibilities
Provides encouragement, support, positive reinforcement to laboratory technicians
Oversees sample labelling, processing and shipping duties as required
Ensures lab set up and cleaning duties are performed on a daily, weekly and monthly basis
Processes biological samples as per lab manual when required
Attends all pre-study meetings, including SIVs and protocol trainings for assigned studies
Reviews/Approves lab manual prior to the start of a study
Ensures sample shipments are organized and sent to clients as per the lab manual and study timeline
Ensures sample shipment checklists and sample manifests are generated and reviewed for all sample shipments
Performs sample processing checks on all studies to ensure compliance with lab manual and SOPs
Ensures the QC of laboratory source data and performs QC as necessary
Works in a safe and responsible manner at all times
Reviews protocol specimen processing requirements and ensures that an adequate inventory of necessary supplies are available or ordered and delivered prior to study start and throughout study conduct
Reviews/approves specimen labels prior to tube preparation
Ensures collection tubes and freezer vials are properly labelled and set up prior to scheduled sample collection
Processes samples and assists with laboratory duties as needed
Assists with SOP reviews and edits
Works with Data Entry team to resolve discrepancies/queries noted during lab tracking or monitoring visits
Assists with training of new laboratory staff and ensures lab staff are fully trained and signed off in the relevant SOP/competency and protocols before working unsupervised or on a study
Additional Tasks/responsibilities
May serve as a backup to the Clinical Laboratory Manager when required
The Candidate
Education or equivalent experience in a science, health or customer related field
Supervisory experience preferred
We are an Equal Employment Opportunity (EEO) Employer.

It has been and will continue to be a fundamental policy of Quotient Sciences not to discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This policy applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

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