As a Research Associate working under direct supervision, you will perform a variety of routine experimental protocols and procedures to support the objectives of one or more laboratory research projects in a specific area of research. Will assist in general laboratory activities, including maintenance of reagents and stocking of supplies as well as file and monitor documents. Will keep accurate and detailed records of experiments and results and assist in the operation of specialized equipment and machinery. Will observe safety standards and procedures and will be able to perform routine cellular, micro- and molecular biology procedures including, but not limited to Western, Northern blot, DNA/RNA, PCR, protein extraction, cell culture, Immunohistochemistry, and staining. This position does not have supervisory responsibilities.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- Performs a variety of routine laboratory tasks and procedures.
- Keeps accurate and detailed project records of experiments and results.
- May assist with animal husbandry.
- Maintains lab equipment and related records.
- Transports, processes and logs samples.
- Maintains computer database with relevant clinical information.
- Performs lab maintenance duties, including glassware cleaning and sterilization.
- Maintains stocks of general lab materials, and places orders for lab equipment and supplies.
- Assists new students and fellows at the laboratory.
- Assists in the operation of specialized equipment and machinery.
- Observes and complies with safety standards and procedures.
DEPARTMENT SPECIFIC JOB SUMMARY:
- Works independently providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
- Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
DEPARTMENT SPECIFIC JOB RESPONSIBILITIES:
- Independent study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details to the research participants, and participating in the informed consent process.
- Scheduling of research participants for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Schedules and participates in monitoring and auditing activities.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings.
- Notifies direct supervisor about concerns regarding data quality and study conduct. Independently works with external study monitors and/or auditors.
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.
- May supervise Clinical Research Associates on data entry, data query and resolution.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
Understanding of general research objectives.
Working Title: Research Associate I – Smidt Heart Institute – Cheng Lab
Department: Heart Institute Operations
Business Entity: Academic / Research
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$18.00 – $29.87