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:

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* + 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:

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* + High School Diploma/GED is required.

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

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* Experience:

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* + One year of clinical research related experience is preferred.

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.