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Clinical Research Manager (Site Manager)

Arizona Liver HealthPeoria, AZ, US

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Clinical Research Manager (Site 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.

Job Summary : Arizona Liver Health / Arizona Clinical Trials is looking for exceptional candidates to fill the Clinical Research Manager (Site Manager) role in Peoria. Qualified candidates will possess great team leadership abilities and a passion for continuing to grow their skillset in clinical research.

Title : Research Manager (Peoria)

Status : Full-time, Exempt, On-site, Monday-Friday, 7am-4pm

Compensation : $100k-$120k per year, depending on experience

Essential Job Functions / Duties :

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.
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

Manager of designated research staff

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 Compliance duties at site as needed

Daily Research Operations

Manager of CRC 1,2,3, Research Phlebotomist

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

Report to PI and Director of Clinical Research on status of 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 PI and Director of Clinical Research

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

Allocate work in cooperation with Director of Clinical Research

30 / 60 / 90- day and annual review for Clinical research staff : CRC, Phlebotomists

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, Director of Clinical Research and Chief Medical Director of Research

Direct / Assist with projects and tasks as assigned

Provide assistance with study protocol adherence as necessary

Ensure site staff completes assigned tasks

Knowledge / Skills / Abilities Required :

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 / teaching skills required

Ability and commitment to training, coaching, and mentoring a team is required

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.

Education and / or Trainings Required :

Bachelors Degree or Graduate degree preferred

Minimum Ten (10) years of Research experience leading a team in high-growth clinical research 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 and Leadership experience and / or related training and certifications is required

Physical Requirements :

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

Travel Requirements :

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

Work Authorization Requirements :

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

Benefits & Perks :

Health, Dental, Vision (with HSA plans and employer contribution)

3 weeks PTO

5 days Sick Time

7 Company Paid holidays + 2 Paid Half-days

401K with 6% company match

Short & Long Term Disability

Educational Assistance

Shared company vehicles for required travel

Our company requires COVID-19 vaccinations for all current and future employees. Exemptions can be requested for those with a reasonable health or a religious / sincerely-held belief accommodation.

EEO statement : 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 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

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Clinical Research Manager (Site Manager) • Peoria, AZ, US