Clinical Studies Associate

Position Summary:

Responsible for performing clinical laboratory duties including IHC staining of human tissue samples for clinical trial studies. Organizes study documentation within the LIMs database and provide assistance to laboratory personnel to increase efficiency of the laboratory. Responsible for receiving human biological samples, patient/specimen data entry into the LIMs database, accurately labeling of samples, and document imaging for related tests performed Discovery. Receives and properly identifies clinical sites where tests are performed. Sorts samples according to protocol. Generates emails to the sponsor and sites for problem samples. Monitoring of sample/test progress and submission of test results to the sites.

Education Requirements:
A minimum of a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution.
Certifications/License/Registration Requirements :

• No Requirements

Qualification/Experience:

Proficiency in IHC technique to stain human tumor samples. Data entry utilizing computer LIMs system. Patient sample management: verification checks and batches samples to the assigned area or individual. Clinical document control and organization. Following established safety guidelines and participates in required ergonomic programs. Understand and follow Good Clinical Laboratory Practices (GcLP). Monitoring of sample/test progress and submission of test results to the sites.

Essential Duties/Responsibilities :

• IHC staining of human tissue samples for clinical trial studies utilizing commercial staining platforms including Leica, Agilent/Dako,
• Organizing study documentation within the LIMs database and provide assistance to laboratory personnel to increase efficiency of the laboratory.
• Receiving human biological samples, patient/specimen data entry into the LIMs database, accurately labeling of samples, and document imaging for related tests performed Discovery.
• Data entry of sample information, labeling of specimens, quality control checks such as verifying specimens received against accompanying requisition forms, notifying relevant personnel of the arrival of the sample, filing of documentation, and maintaining the accessioning area in a clean and tidy condition.
• Adheres to Health and Safety regulations and security procedures always. Contacts the collection site or sponsor when information is incomplete or conflicting to complete the accessioning process.
• Meticulously documents any discrepancies and their resolution.
• Supports company operations through general office tasks, shipping and receiving, maintenance of Sample logs and other databases. Responsible for writing or revising applicable SOPs.
• Uses a computer to enter client data following standard protocol.
• Assists Histology with maintaining an indexed collection of paraffin embedded samples and adding tissues samples as they are acquired and issued as needed for projects or studies including cross-indexing and filing of pathology reports if received with the tissue sample.
• Monitors the progress of sample processing and test workflow and ensures that TAT is kept. Close interaction with pathologists for capturing of test results. Transfer of result certificates back to the sites.

Supervisory/ Line Management Responsibilities:

Insert Here

Travel Requirements:
Domestic: ☒ 0-5% ☐ 5% = 10% ☐ 10% - 20% ☐ 20% - 50% ☐ >50%

International: ☒ 0-5% ☐ 5% = 10% ☐ 10% - 20% ☐ 20% - 50% ☐ >50%

US Work Environment and Physical Requirements(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions):

This job is performed primarily in an office environment, with regular travel to customer locations. The majority of the workday is spent either sitting or standing. Duties require the ability to communicate clearly with internal or external contacts, either verbally or in writing.

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

The tasks, duties, and responsibilities listed in this position description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills and/or education will also be considered so qualifications of incumbents may differ from those listed in the Position Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.

Discovery Life Sciences is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law.