Senior Clinical Research Associate

Integrated Resources, Inc ( IRI )

Santa Monica (CA)

Hybrid

USD 89,544 - 90,921

Full time

14 days+

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Job summary

A clinical research organization is looking for a Clinical Trials Management Associate - III to handle site evaluations and ensure compliance with protocols. The ideal candidate should have over 4 years of relevant experience and a BS or BA in a scientific discipline or an RN certificate. The position is contract-based and offers flexibility for remote work, particularly for candidates located on the West Coast. The candidate should be adept in tools like Word, PowerPoint, and Excel.

Qualifications

4+ years of experience in clinical trials.
Experience in site evaluations and monitoring visits.
Must have knowledge of FDA and/or EMEA Regulations.

Responsibilities

Conduct site evaluations and routine monitoring visits.
Ensure compliance with protocols and regulatory requirements.
Assist in the preparation of safety and interim study reports.
Coordinate with CROs or vendors as needed.

Skills

Site evaluations

Regulatory compliance

Project coordination

Data analysis

Training

FDA regulations knowledge

Scheduling

Education

BS or BA in relevant scientific discipline

RN (2- or 3-year certificate)

Tools

Word

PowerPoint

Excel

Job description

Integrated Resources, Inc ( IRI ) provided pay range

This range is provided by Integrated Resources, Inc ( IRI ). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$65.00/hr - $66.00/hr

Direct message the job poster from Integrated Resources, Inc ( IRI )

Lead Recruiter at Integrated Resources Inc.

Job Title: Clinical Trials Management Associate - III

Location: Considering local candidates to any of the west coast sites: Santa Monica, El

Job Duration: 12+ Months (Possibility of Extension)

NOTE: Working mostly remote but subject to change to comply with policy.

Job Description

With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines.
Assists in CRO or vendor selection.
With guidance from supervisors, coordinate CROs or vendors.
Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
Participate or effectively run meetings and conference calls with CROs, vendors, and multi-functional teams (May participate in abstract presentations, oral presentations and manuscript development).
Interfaces with individuals in other functional areas to address routine study issues.
May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
Under general supervision, participate in two or more departmental or interdepartmental strategic initiatives.
Travel is required.
Working knowledge and experience with Word, PowerPoint, and Excel.
Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
Ability to develop tools and processes that increase the measured efficiency of the project.
Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
Must have a general understanding of functional issues and routine project goals from an organizational perspective.