Cedars-Sinai Clinical Research Coordinator I - Part-Time - Material and Information Resources for Inflammatory and Digestive Diseases (MIRIAD) Biobank in Los Angeles, California
Are you a passionate and dedicated research professional?
The Material and Information Resources for Inflammatory and Digestive Diseases (MIRIAD) Biobank is searching for a Part-Time Clinical Research Coordinator I (CRCI). MIRIAD is the central hub of a full-circle approach to the study of inflammatory bowel disease (IBD). MIRIAD acquires, processes, stores, evaluates and distributes human specimens, which are maintained in association with the triad of accurate longitudinal clinical metadata, comprehensive genotype information and serotypes. These resources are made available to research partners within IBIRI and Cedars-Sinai, and with collaborators around the world. Under the direction of Dr. Jonathan Braun, we are seeking for a hardworking and highly motivated professional to join our efforts!
To learn more, please visit: https://www.cedars-sinai.org/research/departments-institutes/ibiri/miriad-ibd-biobank.html
The CRCI works independently providing study coordination including screening of potential patients 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 on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular staff meetings. Ensure 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 patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Schedules and participates in monitoring and auditing activities.
Schedules patients for research visits and procedures.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / IRB duties, budgeting duties, and assisting with patient research billing and reconciliation.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Department Specific Duties and Responsibilities:
Ability to follow essential regulatory guidelines and ensures the accuracy and confidentiality of phenotype data.
Responsible for updating patient and other subgroups of active MIRIAD patient's post-surgery outcomes and recurrence through chart-review.
Responsible for collecting the exposures, allergy, and side effects of IBD medication from the selected subgroup of active MIRIAD patients.
Assist with database/data architecture transitions.
Maintains and ensures chart-review IBD consultation notes from Epic and fills out Phenotype Form B1/2 on RedCap.
Chart-review surgery-related data for a list of CD and UC patients and enter the data into RedCap.
Responsible for update via chart-review patients surgery data, include a list of essential surgery data fields for future studies.
- Associate degree, required. Bachelor of Science or Bachelor of Arts Degree in biological sciences, sociology or related degree, preferred
- ACRP/SoCRA (or equivalent) certification, preferred
Experience and Skillset:
Two (2) years of directly related experience
Understanding of general research objectives
Working knowledge of database management, personal computers, and presentation and imaging software
Must possess computer skills to include, but not limited to, Excel and Word
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.