Clinical Research Specialist I- Sponsor Investigator Support UnitRequisition # 19002606 Apply Now
The Clinical Research Specialist I - Sponsor Investigator Support Unit provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
DEPARTMENT AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:
• Work with CRO management to develop processes for investigator initiated trials including: developing process workflows, manuals, standard protocol language, forms, worksheets, instructions and tools, establishing template and guidance documents. May also provide input or help develop training materials for staff and/or investigators.
• Provides administrative protocol review to ensure language is consistent with regulatory obligations and helps ensure consistency throughout protocol. Responsible for protocol formatting and version control.
• Assists in protocol writing for standard CRO sections of the protocol and may develop standard language as appropriate
• Supports investigators with all FDA correspondence to ensure compliance with federal regulations for institutionally/PI held IND/IDEs
• Facilitates protocol development and start-up process through parallel work streams and various cores
• Responsible for assisting PI in protocol registration for clinicaltrials.gov and clinical trials reporting program (CTRP) and results posting to applicable sites for IITs
• Maintains appropriate trackers, generates routine and ad-hoc reports and provides project management support to ensure timely protocol development and activation and portfolio management
• Serves as central point of contact and works with cross-functional team members (i.e. biostatistics, research informatics etc) to ensure sound protocol and logistic set up
• May provide regulatory support for IIT/IIS such as IRB submissions, regulatory documents, continuing reviews and ongoing binder maintenance and respond to Quality Assurance (QA) findings by providing corrective/preventative action plans, training, instituting new processes or equivalent
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.
Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
Coordinates research projects at an institutional or departmental level.
Communicates project status and improvement areas with leadership in a timely manner.
Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
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.
May provide fiscal management (i.e. budgeting, accounting, cost projections) for assigned IIT/IISs
This position is eligible for the Employee Referral Program. See website for details: http://careers.cedars-sinai.edu/working-here/employee-referrals/
ACRP/SoCRA (or equivalent) certification preferred.
Three (3) years minimum experience in area of research specialty.
- Working Title: Clinical Research Specialist I- Sponsor Investigator Support Unit
- Department: SOCCI Clinical Research Office
- 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.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.
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