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The Melmed Laboratory focuses on elucidating mechanisms of pituitary tumor development and pathogenesis, translating the study of anterior pituitary function regulation to the clinic and establishing new modalities of diagnosis and treatment for pituitary diseases. Examples of work in the Melmed Lab include acromegaly therapeutic targeting via somatostatin receptor signaling, Cushing disease drug discovery using a zebrafish model for screening of small molecules, and characterization of the human pituitary tumor-transforming gene, critical to pituitary tumor cell cycle outgrowth. To learn more, please visit: Melmed Research Lab | Cedars-Sinai (cedars-sinai.edu).
The Clinical Research Coordinator II 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. May plan and coordinate strategies for increasing research participant enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Job Duties and Responsibilities:
- 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.
- Scheduling of research participants for research visits and procedures.
- Maintains accurate source documents related to all research procedures.
- Schedules and participates in monitoring and auditing activities.
- Notifies 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 / IRB duties, budgeting duties, and assisting with research participant billing and reconciliation.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
- Coordinates training and education of other personnel.
- Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
- Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
- Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
- May identify new research opportunities and present to investigators.
- Participates in required training and education programs including CSMC phlebotomy-specific clinical oversight which encompasses initial training, monthly assessments, six-month assessments, and annual assessments.
- Performs phlebotomy services according to CSMC policies and procedures.
- Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated.
- Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely.
- Reports test results to appropriate individuals and exercises professional discretion with patient information.
- Bachelor's Degree in Science, Sociology or related degree, required.
Experience and Skillset:
- Four (4) years minimum of directly related experience required
- Ability to use discretion and maintain privacy, confidentiality or anonymity
- Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations
- Ability to convey and/or receive written/verbal information to/from various audiences in different formats
- California Certified Phlebotomy Technician I or Certified Phlebotomy Technician II certification, required
- ACRP/SoCRA (or equivalent) certification, preferred
- Working Title: Clinical Research Coordinator II/CPT - Melmed Lab
- Department: Home Dept - Gastroenterology
- 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
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. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
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