Research Laboratory Technician

Job Description

Job Description

Position:

Performs all laboratory duties required by protocol, including phlebotomy, ECG, vitals, and specimen processing. Assist in the daily operation and work in collaboration with Clinical Research Coordinators (CRC) on clinical trials by screening and scheduling patients according to study protocols and site SOPs and GCPs.

Assist in the daily operation of clinical trials by performing laboratory procedures and regulatory duties according to site SOPs, IATA, and GCPs.

Coordination day-to-day trial activities/updating charts and ensuring adherence to study protocols and objectives

Preparing and managing documentation such as case report forms, consent form, and regulatory submissions.

Obtaining informed consent form participants and ensuring their safety and right throughout the trial.

Recruiting, managing, and maintaining accurate study data and patient information.

Utilizing digital tools for protocol review, virtual trial site preparation, and electronic consent management in modern trials.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Maintaining all aspects of the lab

Ushering patients to phlebotomy lab as needed

Processing & Shipping labs

Logging all outgoing packages in LHSI Tracking Log binder

Calling in all packages at the end of the day for pick-up

Temp logs for freezer and fridge in lab supply room

Complete study regulatory packets/updates for submission

Communicate with patient regarding Clinical trials they qualify for and answer any questions they may have before consenting. 

Informed Consent with patients

Maintain study source documents

Completing visits within a subject’s source document accurately, completely, and in accordance with GCP

Completing study visit source documents in a timely manner

Ensuring that all appropriate visit related documentation is present and within the chart (including, but not limited to the below):

Applicable imaging/EKG reports

Updating the subjects logs as applicable (PD, AE, IP, Con Med, Med Hx, etc) at each visit in both the source chart, and yellow chart

Ensuring that the subjects visit is logged on the study tracker appropriately

Monitoring Patients for their visit and managing any adverts events 

Ensuring that the source document aligns with the most updated protocol PRIOR to the patients visit

Prepping assigned patients’ source documents, the day prior to the visit

If the patient does not qualify for a study, filing the chart appropriately

Maintain Study Timelines such as window visit, out of window visits, and unscheduled visits. 

Reviewing Protocols in depth, and ensuring understanding prior to patient visits (New protocols, or updated protocols)

QUALIFICATIONS:

Bachelor’s Degree in Public Health, Healthcare Administration or related scientific field.

Medical Assistant or Phlebotomy certification required. 2 + Experience as Lab Technician or relevant position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LANGUAGE SKILLS:

Ability to read and interpret documents such as safety rules, operating instructions, procedure manuals and clinical research related materials such as a source document or CRF. Ability to write routine correspondence and progress notes.

MATHEMATICAL SKILLS :

Ability to add, subtract, multiply and divide using whole numbers, common fractions and decimals.

REASONING ABILITY :

Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several variables.

PHYSICAL DEMANDS:

The employee may occasionally lift and/or move up to 15 pounds.

We are a dedicated ophthalmology research center focused on advancing treatments for vision and eye health. Our team of experienced investigators and clinical staff conduct FDA-regulated studies designed to improve outcomes for patients worldwide

Company Description

We are a dedicated ophthalmology research center focused on advancing treatments for vision and eye health. Our team of experienced investigators and clinical staff conduct FDA-regulated studies designed to improve outcomes for patients worldwide