Clinical Research Sample Specialist

Description

THIS IS A PART TIME POSITION WITH VARYING HOURS PER WEEK.

Responsible for basic technical PK and clinical laboratory procedures activities (such as, but not limited to, PK runner and splitter, PK tube labeling, tube sorting) in the conduct of clinical trials with emphasis on the safety and welfare of study participants. Performs the practical activities of clinical studies according to protocol, regulatory requirements, SOPs, scope of practice and current training status.

• 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.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.

Ability to identify and distinguish colors.

• Potential for exposure to toxic or caustic chemicals.
• Potential for exposure to blood borne pathogens.

Associate's Degree in a scientific/medical discipline desirable.

• Laboratory experience highly desirable.
• BLS certification required within 6 months of hire or promotion date.

Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.