- Enters data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- Works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
- Schedules research participants for research visits and research procedures.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- May participate in the development of Investigator initiated trials for Investigational New Drug applications and/or Device applications.
- Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Department-Specific Duties: - Enrolls patients for program's research registry.
- Collects patient/family program evaluation data during clinic visits.
- Follows-up post-clinic via phone and electronically to collect programmatic annual evaluations.
- Compiles evaluation data and helps to set up infrastructure for tracking data trends.
- Collects data via chart reviews or patient interviews for potential research projects.
- Contacts participants expressing interest in other research opportunities (i.e., tissue donation).
Qualifications
Qualifications: - High School Diploma/GED is required.
- 1 year of clinical research related experience is required.
Physical Demands:
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
About Us
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the Team
Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : HRC1198366
Working Title : Clinical Research Associate II - Memory Disorders Program - Department of Neurology
Department : Research - Neurology
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $ $36.14 -
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Clinical Research Associate II - Los Angeles, United States - Cedars-Sinai
Description
Job DescriptionWhen 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 great opportunity
The Jona Goldrich Center for Alzheimer's and Memory Disorders brings together Cedars-Sinai clinicians, scientists, patients and their loved ones.
This role will provide support to the Memory Disorders Program's clinical data and research efforts. The clinical programs collect various forms of data (patient level data, program evaluation, caregiver evaluation, patient assessments, etc.), which this position will ensure are collected and compiled for clinical improvement and future research papers, projects, and/or grants.
The Clinical Research Associate II will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for external sponsors. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms (CRFs), entering clinical research data, and assist with regulatory submissions to the Institutional Review Board (IRB). The incumbent may have limited contact with research participants as needed for study and assists with study budget and research participant billing. The CRA II may coordinate activities, training, and education for other CRA members. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities: