Trial Activation Specialist (Study Startup)

Job Description

Job Description

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, 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 qualified candidates for the Trial Activation Specialist (Study Startup) position. This role can be based out of any of our sites.

Title: Trial Activation Specialist (Study Startup)

Compensation: $65,000 - $80,000 per year, depending on experience

Status: Full-time, Salary, Exempt

Schedule: 7am-4pm

Location: Onsite in either Peoria, Chandler, or Tucson Site

Essential job functions/duties

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

• Collaborate with Regulatory and Clinical Trial Acquisition team with communication with Sponsors and Third Parties to acquire feasible trials for ALH/ACT
• Collaborate with teams to develop and implement study start up plans and timelines.
• Facilitate the preparation, review, and submission of regulatory start up documents to study related contacts:
  • 1572
  • Confidential Disclosure Agreements
  • Financial Disclosure Forms/Conflict of Interest Form
  • Privacy Notices
  • Site Contact Forms
  • Source Data Verification Forms
  • Site Feasibility Forms
  • Other forms as needed
• Prepare, review, and facilitate the initial submission of the clinical trial in start up to the Central IRB for board review.
• Ability to manage multiple projects across multiple sites simultaneously
• Creation of CRIO Shells for electronic documentation during study start up:
  • Configuration of staff in CRIO for accuracy
  • Template maintenance
• Assist in requests for any regulatory documents/credentials/certificates during the study start up period
• Coordinate and host PSV/SQV and schedule SIV for each research site
• Communication with Research Managers, Marketing, Operations, and other Site Staff on study start up activities.
• Ensure adherence to applicable regulatory requirements, guidelines and Good Clinical Practice (GCP) standards.
• Maintain accurate and up-to-date study start-up documentation, including tracking systems, databases (Monday), and study files.
• Perform internal review and coordinate with various departments to ensure study activation in a timely manner
• Managing DOA and training logs until site activation is granted
• Attend routinely held meetings with Administration to communicate status of trials in start-up.

Knowledge/Skills/Abilities Required

• Regulatory Compliance: Understanding and staying updated on the regulatory requirements governing clinical trials, such as Good Clinical Practice (GCP) guidelines and local regulations.
• Protocol and Study Design: Familiarity with clinical trial protocols and the ability to assess their feasibility, identify potential challenges, and provide input during protocol development.
• Documentation and Record-Keeping: Proficiency in preparing and maintaining regulatory documents, such as investigator brochures, informed consent forms, and study protocols. Strong organizational skills for maintaining accurate and up-to-date records.
• Ethics and Compliance: Knowledge of ethical considerations in clinical research, including patient confidentiality, informed consent, and protection of human subjects. Adherence to ethical standards and the ability to navigate ethics committee submissions.
• Organizational skills: Ability to effectively manage multiple tasks, timelines, and stakeholders. Strong planning, coordination, and prioritization skills to ensure efficient study start-up processes.
• Communication and Collaboration: Excellent verbal and written communication skills for interacting with investigators, study site staff, and sponsors. The ability to foster collaboration and build positive relationships.
• Attention to Detail: Meticulousness in reviewing study documentation and ensuring accuracy and completeness. Ability to identify potential errors or inconsistencies.
• Continuous Learning: Actively seeking professional development opportunities to enhance knowledge and skills in clinical trial management.

Education, credentials, and/or trainings required

• High School Diploma or GED required
• Clinical research experience or experience working in a medical center or private practice
• Experience using CTMS system and EDC program

Supervisory responsibilities

• None

Work environment

• Clinic setting

Physical demands

• Able to lift at least 15 lbs.
• Able to sit for long periods (at least 50%)
• 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

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

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. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.

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 pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.