Clinical Research Coordinator III - Medically Associated Science & Technology Program (MAST) - Mathur Lab
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, and it’s just one of the many reasons why we rank as one of the top hospitals in the nation by U.S. News & World Report. From working with a team of committed healthcare professionals to using state-of-the-art facilities, you’ll have everything necessary do something incredible—for yourself and for others.
Do you have a passion for helping human kind?
The MAST program at Cedars-Sinai Medical Center is dedicated to the development of novel drugs and devices to diagnose and treat patients. This innovative program is working to develop new diagnostics and therapeutics to treat patients with illnesses related to imbalances or alterations in the microbiome. Over the last 20 years, the MAST team has made many discoveries that benefit millions of patients, and we hope to help millions more with our growing fleet of novel diagnostics and therapeutics. To learn more, please visit: https://www.cedars-sinai.org/research/areas/science-tech.html
Our research is focused on associates between acute gastroenteritis and disruption of gut flora, impairment of GI tract motility, and small intestinal bacterial overgrowth in the pathophysiology of irritable bowel syndrome. There is a strong focus on clinical and translational research. Projects may include, but are not limited to invetigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
As a Clinical Research Coordinator III (CRC III), you will work closely with the Division Program Manager, Clinical Research Coordinator Team and Scleroderma Center Investigators to harmonize clinical research and clinical care efforts by streamlining workflows as needed in the context of dynamic clinical setting. You will provide 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. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
- Responsible for oversight of studies assigned within the group and provides support with managing the clinical research portfolio and daily operations of studies for the investigator or disease group.
- Provides study coordination for assigned projects, including patient screening and consenting, regulatory reporting, completion required data collection, maintenance of source documents, facilitation of all study logistics to ensure successful protocol implantation and patient safety.
- Scheduling of research participants for research visits and procedures.
- Participates in project feasibility reviews and study initiation visits and provides strategic guidance on study set-up and implementation.
- 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.
- Maintains accurate source documents related to all research procedures.
- Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
- 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; present this information at regular research staff meetings.
- Advises direct supervisor about concerns regarding data quality and study conduct.
- 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.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Bachelor of Arts or Sciences degree, required
- 5-7 years minimum of directly related experience, required
- ACRP/SoCRA (or equivalent) certification, preferred.
- Working Title: Clinical Research Coordinator III - Medically Associated Science & Technology Program (MAST) - Mathur Lab
- Department: Home Dept - Medicine Research
- Business Entity: Academic / Research
- City: Los Angeles
- Job Category: Academic/Research
- Job Specialty: Research Studies/Clinical Trials
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Day
- Recruiter: America Juarez Valladares
Cedars-Sinai is an EEO employer and does not unlawfully discriminate on the basis of race, religion, origin, citizenship, ancestry, disability, legally protected medical condition, marital status, sex, sexual orientation, gender identity, gender expression, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. We will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
As an employee, you can apply to this internal job posting.