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Arizona Liver Health · 1 day ago

Assistant Research Manager (Peoria)

Peoria, AZ

Full-time

Onsite

Mid, Senior Level

$90K/yr - $110K/yr

5+ years exp

Arizona Liver Health (ALH) is dedicated to advancing medical innovation through clinical trials and ensuring patient safety. They are seeking an Assistant Research Manager to oversee clinical research activities, manage staff, and maintain compliance with regulations.

Clinical TrialsHealth CareHospitalityMedical

No H1B

Responsibilities

Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities

Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs

Collects and records clinical research data, assists in patient assessments, scheduling, maintaining study files, study supplies and study medication accountability

The day-to-day operations of the research program

Approve flexing of time worked in the absence of the Site Research Manager

Assist in the managing of the site research staff as directed by the Site Research Manager

Train/retrain new research staff in addition to executing regular retrainings with current staff to maintain compliance and productivity

Along with the Site Research Manager, review weekly screening and clinic volume to meet and/or exceed goals

Regulatory and /or Quality Assurance/Quality Control duties at site as needed

Daily Research Operations

Assist in the managing of CRC 2, 3, research phlebotomist in the absence of the Site Research Manager

Report any daily issues/concerns, work quality issues to the Site Research Manager

Provides support to the site manager and clinical staff to ensure high quality, high volume and efficient productivity

Help plan site specific team building activities

Report to direct manager on status of daily clinical research operations

Maintain effective, and positive, working relationships with patients, sponsors, providers and employees

Troubleshoot and resolve clinic, protocol, and SOP issues and advise CRCs

Changes to SOPs and clinic process to be discussed with Chief Medical Officer and direct manager

Assist ad fill in for CRCs (level 1-3) with assigned tasks as necessary

Allocate work in cooperation with the Site Research Manager

Conduct timely evaluations and monthly one-on-one meetings (at minimum) for assigned direct reports (if any)

Assist in establishing and enforcing departmental standards

Assist in conducting regularly scheduled meetings with the research personnel at the site as needed and take proper meeting notes with action items

Attend and present at scheduled meetings with research staff, direct manager, and Chief Medical Director of Research

Assist with projects and tasks as assigned and direct in the absence of the Site Research Manager

Provide assistance with study protocol adherence as necessary

Ensure site staff completes assigned tasks

Qualification

Clinical research managementRegulatory complianceGCP knowledgeFDA knowledgeClinical trial managementTeam trainingLeadership skillsCustomer serviceInterpersonal skillsTime management

Required

At least three (3) years of experience in a lead CRC role or a CRC III role or equivalent in either phase 1 or phase 2-3 research

A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics

Strong Interpersonal and communication and customer service skills, both verbal and written

Able to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects and referral sources. Can communicate clearly and effectively

Strong organization, time-management, and leadership skills

Ability to maintain professional and positive attitude

Ability to provide all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum

Knowledge of FDA regulatory requirements is required. Has knowledge of commonly used concepts, practices and procedures within particular field. Rely on instructions and pre-established guidelines to perform the functions of the job. Work under immediate supervision of the Site Research Manager

Proven ability to perform all job functions as listed job descriptions for Research Phlebotomist, CRC I-III, and Research Pharmacy Tech

High School Diploma or GED required

Associates, undergraduate, graduate degree or equivalent

Five (5) years of work experience or graduate training preferably in clinical setting

Study-specific training

Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation and trial management)

Able to lift at least 25 lbs

Able to sit for long periods (at least 50%)

Able to type and do computer work for long periods

Must have valid documentation and authorization to work in the U.S. for any employer. Sponsorship, work visa, and/or visa transfer is not provided