Job description

Overview:

Our client, a Medical Center facility under the aegis of a California Public Ivy university and one of largest health delivery systems in California, seeks an accomplished Regulatory Clinical Research Coordinator.

*** Candidate must be authorized to work in USA without requiring sponsorship ***

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*** Location: 924 Westwood Blvd. Suite 420, Los Angeles, CA 90024

*** Duration: 5 months contract w/ possibility of extension

Notes:

· Onsite role.

· Shift: 8:00am - 5:00pm.

· Interview Process: 2 step interview process via Zoom.

Description:

· Assist Principal Investigator, study coordinator, and team members in protocol review and study preparation, to ensure that study is sound from a regulatory and operational point of view.

· Act as primary liaison between Principal Investigator, Senior Management, study team, sponsor, regulatory agencies/committees, Investigational Drug Services (IDS) Pharmacy, and appropriate departments (Laboratory, Radiology, Pathology, Cardiology, CTRC, etc.) in discussion of study requirements.

· With input from the Principal Investigator and study team, prepare and complete the appropriate regulatory documents for submission to the appropriate regulatory agencies/committees in order to obtain study approval.

· Prepare and maintain study-specific regulatory files (binders) with all appropriate study-specific documentation.

· Assist with the preparation of study initiation presentation materials for Investigator Initiated studies and Sponsored studies if required, including protocol, IB, study source documents, CRFs, slides, study handouts, overhead presentations, and lab and procedure manuals. Assist team with ensuring that all study team members and/or satellite sites have received the materials prior to study initiation events (teleconferences and/or meetings).

· Attend study initiation meetings and participate in study initiation and staff training events (teleconferences and/or meetings) for on-campus clinics, and satellite sites. Assist study team with training and orientation of treatment staff regarding protocol requirements.

· Ensure that all approvals (contract, ISPRC, MRSC and IRB) required for study activation occur.

· Notify the study team to begin enrollment upon receiving approval from Sponsor and verifying the study is in Care Connect.

· Uploading all study specific documents (Protocol, IB, ICF and patient materials) into the clinical research management system (CRMS) for study team use.

· Updating study status in CRMS to reflect activation for main campus and all participating satellite sites.

· Coordinate training teleconferences for staff unable to attend the study initiation meeting.

· Track study start-up times, create processes to decrease them, set goals and apply metrics to measure outcomes. Report directly to the Executive Committee with results and recommendations for further improvements.

· Develop, maintain, and modify Standard Operating Procedures designed to ensure efficient and effective compliance with Data Safety Monitoring Board and FDA rules, such as maintaining training requirements and meeting reporting deadlines. These SOPs will be followed by the clinical trials unit.

· Analyze protocol and ensure that procedures are in line with Coverage Analysis directives and advise Principal Investigator on recommend solutions as required. Align informed consent document with these directives.

Qualifications:

· Regulatory clinical research experience.

· Someone familiar with the start-up process: IRB submissions, essential documents submissions to contract offices, budget development, consent development, etc.

· Flexibility. Able to multitask and prioritize competing deadlines.

· Highly Preferred: Experience in regulatory affairs.

· Preferred: Dynamic, Proactive, Attention to detail.

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I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Satwinder “Sat” Singh

Lead Technical Recruiter

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally, as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.

Job Types: Full-time, Contract

Salary: $30.00 - $33.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Los Angeles, CA 90024: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Regulatory Clinical Research: 1 year (Required)
• Regulatory Affairs: 1 year (Preferred)

Work Location: In person

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