Clinical Research Sample Specialist

Position: CLINICAL RESEARCH SAMPLE SPECIALIST BASIC
Education Level Not Specified
* With supervision, ensures that clinical trials are conducted according to protocol requirements by utilizing the following techniques & procedures.
* Performs proper and accurate sample management, including transport, and/or processing of biological (blood, urine, etc) subject samples.
* Appropriately and accurately generates/applies specimen labels for safety lab, PK sample, and/or aliquot samples.
* Documents all sample processing accurately within associated computer systems
* Centrifuges and prepares aliquots for protocol-specified storage and proper sorting of samples
* Maintains specimen requirements at all times according to protocol
* Pipettes plasma/serum efficiently, safely, and accurately
* Maintains all laboratory standards, according to practice
* Reviews Study Specific Trainings and applicable protocols for a thorough understanding of the study procedures, as they apply to their role and ensures that Delegation of Authority/Training Log for each study is completed in a proper and timely manner.
* Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
* Observes and maintains all HIPAA, OSHA, and Exposure Control regulations and Emergency Response as required by applicable training.
* Creates and maintains accurate records of all protocol activities and events, as delegated and trained.
* Follows progress of volunteers and provides for their care, comfort and safety by attending to their needs during study participation.
* Participates in quality assurance of clinical research projects and initiates the need for same as it impacts on clinical practice.
* Ability to read, write and interpret the English language.
* Portrays professionalism in all interactions at Spaulding Clinical.
* Laboratory skills and technique in aliquoting plasma, urine and stool samples
* Strong computer skills; inclination to adopt technology to maximize efficiency
* Demonstrates strong analytical, problem solving skills
* Strong written and verbal communication skills.
* Detail oriented, good organizational traits.
* Self-motivated
* Must be results-oriented, multi-tasking, quick learner, respond to the urgent needs of the team, and show a strong track record of meeting deadlines.
* Ability to work beyond normal work hours and various shift availability required.
* Ability to perform and record data entry via computer systems while conducting timed clinical procedures.
* Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
* Ability to lift and/or move up to 25 pounds.
* Specific vision abilities required by this job include clarity of vision both near and far.
* Laboratory experience highly desirable
* BLS certification required within 6 months of hire or promotion date
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