Clinical Research Associate II (CRA II)

at  AriBio

JOB DESCRIPTION

Role: Clinical Research Associate II (CRA II)
Reporting to: Director, Clinical Operations
Department: Clinical
People Manager: No
Schedule: Hybrid; 4 days per week out of San Diego office.

JOB SUMMARY

The CRA II is instrumental in ensuring the successful execution and oversight of clinical trials. This role involves close collaboration with cross-functional teams to manage and support clinical studies in compliance with all applicable regulations, guidelines, and SOPs.

MINIMUM REQUIREMENTS

• Bachelor’s Degree required (in life sciences field, preferred).
• A minimum of 5 years of clinical research monitoring experience.
• Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.) and a strong understanding of clinical trial processes, protocols, and medical terminology.
• Participation in global Phase 3 trials in CNS indications, preferred.

SKILLS/QUALIFICATIONS

• Comprehensive knowledge of ICH-GCP guidelines and local regulatory requirements.
• Proficiency in Microsoft Office Suite, CTMS, EDC, and other relevant project management systems.
• Strong monitoring skills to independently conduct all types of site monitoring visits.
• Highly self-motivated and well-organized.
• Ability to develop solutions to a variety of complex problems and initiatives.
• Flexibility in problem solving and work hours to meet business objectives.
• Strong team player with a demonstrated track record of success in a cross‐functional team and fast-moving environment.
• Excellent organizational, computing, and oral/written communication skills
• Strong critical thinking and decision-making skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to read and comprehend policies, procedures, instructions, etc., to write reports, to use logic and data to solve problems, to assess needs, and varying degrees of independence, judgment, and discretion.

WORK LOCATION & TRAVEL REQUIREMENTS

• This position is primarily on-site and is located in our San Diego, California office.
• Remote work is currently available one day per week and may be coordinated with your supervisor.Willingness to travel as required by the study protocol (approximately 50%).

PHYSICAL REQUIREMENTS & ENVIRONMENTAL CONDITIONS

• The duties of this role are generally conducted in an in-office environment. As is typical of an office-based role, employees must be able, with or without an accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others (in-person interactions with other persons in indoor and outdoor settings); stand and/or move about the office or in various environments or from one worksite to another.
• Able to travel, including international travel, without personal assistance.
• The above physical requirements and work environment characteristics generally reflect those of this position but is not an exhaustive list. Reasonable accommodations may be made to enable individuals with qualified disabilities to perform the essential functions of the position, provided that such accommodation does not impose an undue hardship on AriBio.

EQUAL OPPORTUNITY EMPLOYER

As an equal opportunity employer, AriBio is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by applicable law. All employees, officers, and representatives of AriBio are expressly prohibited from engaging in unlawful discrimination, harassment, or retaliation.
Consistent with all applicable requirements, AriBio will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless doing so would create an undue hardship on the company.
AriBio also complies with all applicable federal, state and local laws governing work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and Immigration Reform and Control Act.
Nothing in this job description restricts AriBio’s right to assign or reassign duties and responsibilities to this role at any time in its discretion. While this job description generally reflects AriBio’ current assessment of the essential functions for this role, it is not intended to be a complete list of the duties and responsibilities of this role, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice.
Unsolicited resumes from third party vendors will not be accepted

• Conduct comprehensive monitoring visits (PSVs, SIVs, IMVs, COVs) to ensure compliance with the clinical trial protocol, SOPs, ICH-GCP, and other regulatory requirements.
• Lead site training sessions and ensure accurate documentation and data collection in clinical trials.
• Manage site performance, addressing site issues to align with project goals and timelines.
• Review and validate clinical site activities, ensuring precise data capture and reporting.
• Develop and maintain tracking systems for study details, site compliance, patient recruitment, and trial metrics.
• Support the development and review of study materials, including CRFs and informed consent documents.
• Assist with the management and resolution of data queries to maintain data integrity.
• Contribute to the ongoing quality review and final reconciliation of the Trial Master File (TMF).
• Other duties as assigned.