Research Manager (Flagstaff)

United States·Flagstafflead

OtherResearch Manager

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Overview

About Us: Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance,

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OtherResearch Manager

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.

What We Offer

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Reasonable accommodation(s) may be made to enable individuals with disabilities to perform these essential functions.

✓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.

✓Ability to perform CRC responsibilities as listed in the Job Description along with the following: The day-to-day operations of the research program

✓Approve flexing of time worked

✓Collaborate with recruitment team to recruit patients into trials and meet site visit and revenue goals

✓Execute accurate data entry into the EDC and CTMS for patient visits and other pertinent research information as required

✓Train/Retrain new research staff with annual retraining and, as needed

✓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 Manager of CRC 2, 3, research phlebotomist, pharmacy technicians and other research personnel outside of advanced practice providers

✓Daily issues/concerns, work quality

✓If needed, triage issues for escalation to Director of Clinical Research. Serious issues to be referred to Director of Human Resources and Chief Medical Director of Research immediately as well.

✓Provides leadership and support to the clinical staff to ensure high quality, high volume and efficient productivity. Site specific team building activities

✓Proactive team building

✓Incentive/Rewards

✓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 Director of Clinical Research

✓Ability to execute and fill-in for CRCs (level 1-3), phlebotomists, pharmacy techs, and patient recruitment with assigned tasks as necessary

✓Assist in establishing and enforcing departmental standards

✓Conduct weekly meetings with the research personnel at the site

✓Attend and present at scheduled meetings with research staff and leadership

✓Direct/Assist with projects and tasks as assigned

✓Provide assistance with study protocol adherence as necessary

✓Ensure site staff completes assigned tasks

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 Director of Clinical Research.
Able to perform all Job duties listed for Job Description for Phlebotomist.

High School Diploma or GED required
Associates, undergraduate, graduate degree or equivalent
Seven (7) 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)
Managerial experience and/or training

Requirements

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Able to lift at least 25 lbs.
Able to walk and stand for at least 50% of the day
Able to sit for at least 50% of the day
Communicate: hearing, talking, vision
Able to type and do computer work for long periods

Some interoffice travel may be required with use of company vehicle or mileage reimbursement

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

It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities.

Other duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Other responsibilities may be communicated directly by the reporting manager/supervisor. Duties, responsibilities, and activities may change at any time with or without notice.

Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and forceful inquires may also be blocked across our network at the domain level as spam. Thank you for your understanding.