Research Coord/Lab Specialist

About the role

Facilitates all research biospecimen management requirements for tissue, blood and other specimen protocols related to research studies.

Responsible for protocol specific requirements for each assigned protocol as well as good clinical practices as set forth by federal regulations.

Works with the Investigators, Pathologists, Research Nurses, Data Specialists, Monitors/Auditors, and others regarding all research biospecimen procurement and data requirements for specific protocols.

Works with the research team, hospitals, and outside facilities such as physician's offices, pathology partners, and labs, to gather and assemble data and source documentation specific to the protocol.

Works with sponsors and leadership to secure and maintain quality instrumentation required for specimen collection, storage, and shipment.

Accountable for research lab supply inventory.

Actively works to reach expected targets for biospecimen trial participation and enrollment (seeks new study opportunities for site participation, consents patients as appropriate, collects biospecimens/data, etc.).

Ensures research lab safety and compliance.

Ensures integrity of research biospecimens.

Responsibilities

• Facilitates all research biospecimen management requirements for tissue, blood and other specimen protocols related to research studies.
• Responsible for protocol specific requirements for each assigned protocol as well as good clinical practices as set forth by federal regulations.
• Works with the Investigators, Pathologists, Research Nurses, Data Specialists, Monitors/Auditors, and others regarding all research biospecimen procurement and data requirements for specific protocols.
• Works with the research team, hospitals, and outside facilities such as physician's offices, pathology partners, and labs, to gather and assemble data and source documentation specific to the protocol.
• Works with sponsors and leadership to secure and maintain quality instrumentation required for specimen collection, storage, and shipment.
• Accountable for research lab supply inventory.
• Actively works to reach expected targets for biospecimen trial participation and enrollment (seeks new study opportunities for site participation, consents patients as appropriate, collects biospecimens/data, etc.).
• Ensures research lab safety and compliance.
• Ensures integrity of research biospecimens.

Requirements

• A minimum of two (2) years of research experience in a healthcare setting.
• A Clinical Research Certification; or must obtain within one (1) year of becoming eligible.
• Appropriate training for Research Team Members (must be obtained within thirty (30) days of hire).
• Appropriate training for shipping lab specimens (must be obtained within thirty (30) days of hire).

Qualifications

• A minimum of a two-year Associate's degree in health care is preferred.
• Tissue and blood collection trials expertise is preferred.
• Experience with IRB and regulatory requirements is preferred.
• Knowledge of computer technical skills and maintenance of data collection and submissions is preferred.
• Ability to interpret components of medical records, including pathology, radiology, history and physical, operative and discharge reports is preferred.
• Effective oral and written communication is preferred.
• Ability to successfully interact and establish relationships with physicians and health care professionals is preferred.
• Ability to work independently and shift priorities with flexibility is preferred.
• Ability to coordinate a multitude of tasks in a fast-paced environment is preferred.

Skills

• Ability to facilitate research biospecimen management.
• Knowledge of federal regulations and good clinical practices.
• Ability to work with various stakeholders including investigators, pathologists, and monitors.
• Ability to gather and assemble data and source documentation.
• Ability to secure and maintain quality instrumentation.
• Ability to manage research lab supply inventory.
• Ability to ensure biospecimen integrity and research lab safety.

Benefits

N/A

Pay

N/A

Schedule

N/A