Trial Activation Specialist (Study Startup)

Arizona Liver Health•Peoria, AZ

4d•$65,000 - $80,000•Onsite

About The Position

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. 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.

Requirements

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.
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

Responsibilities

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.