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Job Description
Position Title:
Laboratory Specialist
Department:
Clinical Operations
Reports To:
Assistant Operations Manager, Operational Manager, or Sub-Investigator (site dependent)
Direct Reports:
N/A
POSITION FUNCTION
The Laboratory Specialist is responsible for performing routine laboratory sample collection on study participants, and processing and shipping per study protocol and lab manual. The Laboratory Specialist will also assist with data management, research administrative tasks, and recruitment initiatives.
Organization Summary
Our Passionate Cause:
Revolutionizing Research & Changing Lives!
Organization Profile:
IACT Health, LMC Manna Research, and True North Clinical Research joined forces in late 2021 to become Centricity Research. Centricity Research is a clinical research organization with more than 40 sites, access to over 1.6 million patients, and more than 150 active investigators across Canada and the southeastern United States. Our name, Centricity Research, was purposefully chosen to signify the fact that we are customer centric. Our patient volunteers, sponsors, CROs, and physicians are the cornerstone of our business. The name Centricity Research also highlights the fact that our organization has earned a position of prominence and importance within the industry. We aim to build and nurture strong, trusting relationships with all audiences, and being customer-centric is embedded within our company culture.
FUNdamentals:
Centricity Research recognizes the following core values as being essential characteristics for individual and collective success:
- Dream Big
- Go Above and Beyond
- Do The Right Thing
- Be Curious
- Have Fun
Essential Functions
- Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations
- Maintain professional relationships with study participants, physicians, industry representatives and vendors of trial management
- Perform phlebotomy, sample collection, processing & shipping as required by protocol, laboratory manual, SOP and company guidelines
- Complete the requisition, collection, labeling, storage, and shipment of specimens
- Conduct blood glucose testing for diabetes patients, as required
- Perform other in-house testing and/or point of care testing ie. nasal swabs, as required
- Perform ECGs, vital signs, meal distribution, study participant monitoring, phlebotomy, and other clinical procedures, as required by protocol/site
- Review and record daily temperature, respond to temperature excursions
- Perform monthly and annual maintenance on temperature monitoring system, as required
- Ensure that all equipment used in clinical research studies is inspected, calibrated and maintained with supporting documentation, as required
- Perform PBMC collection, receipt of samples, isolation, cryopreservation, as required by site
- Maintain PBMC supplies, documentation, and samples, as required by site
- Assist CRPs with duties such as IP receipt, accountability and dispense QC, CRF data entry, database query review, preparation of study charts, essential document maintenance
- Assist with archiving study and study documents upon completion of a study
- Assist with recruitment initiatives at the site
- Maintain adequate clinical supplies as required
- Assist in organizing waiting areas, exam rooms, laboratories, medication areas, and storage areas
- Assist the Research Management and Investigators with any other research tasks as required
Education/Experience
Minimum:
- Completion of a Laboratory Technician or Assistant program at a recognized College or University. A minimum of 6 months of phlebotomy experience, preferably in a clinical research environment
Preferred: :
- OSMT, CSMLS certified or equivalent
- MLT diploma or certification, an asset
- Phase I-IV Clinical Research experience is considered a strong asset
Core Competencies/Skills
Prerequisite (Essential):
- Excellent communication skills (verbal and written)
- Excellent computer skills (MS Word, Excel and Outlook)
- Attention to detail
- Ability to manage time efficiently
- Self-directed
- Teamwork & Collaboration
- Proficient level of clinical, interpretive and analytical skills with organizational skills for project planning
- Flexible & Adaptable
- Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines
Foundation:
- Conflict resolution
- Receptive to feedback
- Empowering & Developing others
- Empathy Skills
- Planning and organizing skills
- Excellent problem-solving skills
- Achievement oriented
- Analytical ability
- Initiative
- Decision making
Leadership:
- Forward thinking
- Innovative
- Creative
- Strategic thinking
- Self confidence
- Strong interpersonal skills
PHYSICAL DEMANDS
- Physical demands include but not limited to prolonged sitting, light lifting, standing, reaching, walking, and bending.
- Frequently required to complete work on the computer in a seated position
- May be required to lift light boxes (10 – 20lbs)
WORKING CONDITIONS
- Modern medical office environment.
- Required to follow all healthcare industry OHSA and OSHA guidelines
- Required to perform duties in relation to PHIPA, HIPAA, PIDEDA
- Some positions may require overnight/weekend hours
Benefits
- Opportunities to work with internationally renowned physicians
- Comprehensive health benefits, competitive salary
- RRSP and 401(k) contribution matching
- Continued opportunities for growth & development; yearly education allowance
- Paid holiday closures and employee appreciation days off
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