Job description

Research Associate - Administrative

Location: 1000 Veteran Ave 32-59, Los Angeles, CA 90095 (Hybrid, 3 days On-site)

Shift Timings: TBD

Duration: 6 months+ (possible extension)

Pay Rate: $28.00/hr.

Required: Research Regulatory experience (amendment/continuing review submissions)

Preferred: Clinical research experience, Epic system, Microsoft Suite.

This position will maintain all research regulatory support for the Division of Rheumatology.

Job Summary:

· Under the direction of the Research Coordinator Supervisor, provide general administrative support to the research team as needed.

· Assist in preparing reports for agencies, data analysis, presentations, regulatory documents and project budgets.

· Responsible for preparation and submission of required regulatory documents such as CV's, Laboratory Certificates, FDA Forms including FDA IND, 1572's, financial disclosure forms, training certificates, delegation of authority forms, Pharmacy logs, IRB approvals, and misc. paperwork required for study compliance to study sponsor for each research protocol.

· Preparation of applications for regulatory agencies such as IRB and CTAO.

· Responsible for preparation and submission of required regulatory documents such as CV's, Laboratory Certificates, FDA Forms including FDA IND, 1572's, financial disclosure forms, training certificates, delegation of authority forms, Pharmacy logs, IRB approvals, and misc. paperwork required for study compliance to study sponsor for each research protocol.

· Prepare and submit to IRB study documents such as study protocols, Investigator Brochures, ICFs, monitor/DSMB reports, and applicable safety reports.

· Prepare and submit to IRB all updated study documents as they become available.

· Respond to IRB and sponsor questions. Change the Inform Consent based on collaboration with the sponsor and IRB. Resubmit the requested changes to the committees in a timely manner.

· Maintain close communication with Principal Investigator and study team regarding status of regulatory documents and sponsor approvals for study documents.

· Review all study protocols, Investigator Brochures, and applicable safety reports with the Principal Investigator and all study personnel.

· Document all communications with study sponsors.

· Review study budgets based on protocol procedures to delineate standard of care vs. study driven procedures.

· Submit appropriate budget price requests to UCLA ancillary department in order to obtain current research prices.

· Set up accounts for radiology, pharmacy, CTRC, ECG, and UCLA labs.

· Submit sponsor approved study budget to UCLA budget committee.

· Initiate and participate in budget negotiations with study sponsors as appropriate.

· Implement changes to the study budget in order to produce a final approved study budget.

· Communicate directly with fund manager, and contracts and grants office once the final budget is approved.

· Submit protocol, final budget, contract documents and necessary paperwork per policy.

· Maintain all study required regulatory documents for accuracy and completeness.

· Prepare and submit study procedures cost invoices to study sponsors.

· Maintain accurate records of all invoices and study procedure costs

· Review, track, and submit serious adverse events that occur at UCLA for review by the study sponsor, IRB and ISPRC/DSMB (when necessary).

· Prepare and submit annual study renewal to IRB in a timely manner.

· Prepare and submit final study closure notifications to appropriate committees such as IRB and contracts and grants.

· Experience with the budget/contract side of research.

Administrative Support:

· Prepares and submits necessary documents to set up Pharmacy, Radiology, CTRC, and other ancillary department accounts for UCLA research protocols.

· Prepare agenda for and attend staff meetings.

· Schedule and attend study initiations and closure visits, prepare and maintain all study initiation and closure documents as necessary.

· Participate in study sponsor teleconferences to discuss and resolve all outstanding study issues and study updates.

· Organize and prepare SUSAR reports provided by the sponsor for PI review and make the appropriate regulatory submissions.

Skills, knowledge and abilities:

· Strong interpersonal skills for interaction to communicate diplomatically and effectively with faculty, peers, patients, physicians, collaborators, researchers, administrators, and University faculty and staff.

· Familiar with the IRB systems (Central exp. Advarra/WCG).

· Demonstrated skill in problem solving, prioritizing assignments to complete work in a timely and efficient manner, maintaining confidentiality of data and using discretion and judgment in responding to inquiries and releasing information.

· Ability to work as a team and work independently with minimal direction.

· Demonstrated skills in using PC computer, MS Word, MS Excel, PowerPoint, Internet and Windows applications.

· Skills to obtain or convey clear information at various organizational levels.

· Ability to work flexible hours, including weekends.

· Ability to transmit correspondence by facsimile.

· Ability to shift priorities and adapt to changes.

Client training:

· Working knowledge for IRB submissions.

· Ability to work with frequent interruptions.

· Ability to attend to many details within a short span of time.

· Skill in telephone business etiquette.

· Skill in interacting with persons on a one-to-one basis of various social and educational backgrounds and age.

· Skill in writing legible, concise and grammatically correct documentation in standard English.

· Spanish fluency Preferred.

Job Type: Full-time

Salary: $25.00 - $28.00 per hour

Benefits:

• Paid time off

Schedule:

• 12 hour shift
• 8 hour shift
• Day shift
• Monday to Friday
• Night shift

Ability to commute/relocate:

• Los Angeles, CA 90095: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Are you a US citizen or a GC holder?

Education:

• High school or equivalent (Preferred)

Experience:

• Clinical trials: 1 year (Preferred)
• Research: 1 year (Preferred)
• Epic: 1 year (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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