Clinical Research Associate - Medically Associated Science & Technology; MAST Program

Position: Clinical Research Associate I - Medically Associated Science & Technology (MAST) Program
Job Description

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.

We invite you to consider this phenomenal opportunity!

As a Clinical Research Associate I, you will work under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of non-complex research studies. The incumbent will support objectives of research studies through non-complex tasks such as data collection, pre-screening and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

Primary

Job Duties and Responsibilities:

* Collects, evaluates and/or abstracts clinical research data.

* May assist in designing forms for data collection/abstraction.

* Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.

* Completes Case Report Forms (CRFs).

* Schedules research participants for research visits and research procedures.

* Provides supervised patient contact or independent patient contact for long term follow-up patients only.

* Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.

* Assists with clinical trial budgets and patient research billing.

* Responsible for sample preparation and shipping and maintenance of study supplies and kits.

* Ensures compliance with protocol and overall clinical research objectives.

* Maintains research practices using Good Clinical Practice (GCP) guidelines.

* Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

* May serve as one point of contact for external sponsors for select trials.

* May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

Department-Specific Duties:

* Maintains CITI certification.

* Compiles, analyzes, and presents work at internal meetings and conferences.

* Performs data searches and other related administrative tasks.

* Assists with research protocol writing and development.

* Assists with prescreening of research participants for various clinical trials.

* Attends research meetings and monthly conference calls with sponsors.

* Maintains organized paper and electronic research files.

* Performs all data collection and data entry tasks for departmental clinical studies.

* Assists with preparing manuscripts, letters, and other research documents as needed.

* Coordinates study related activities and subject recruitment with Laboratory Staff.

Qualifications

Education:

* High School Diploma/GED is required.

* Bachelor's degree in Science, Sociology, or related degree is preferred.

Experience:

* One year of clinical research related experience is preferred.