Clinical Research Associate II

Avania; United States; On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation and benefits

Travel opportunities

Training and development opportunities

Job summary

Avania is seeking a Clinical Research Associate II (CRA II) with cardiovascular trial experience to support medical device clinical trials. This role involves site monitoring, SIV visits, and extensive travel, with responsibilities including site initiation, SDV, data reviews, and regulatory submissions.

You will engage with investigators, ensure protocol adherence, and maintain trial documentation per GCP, ISO 14155, and FDA requirements. Strong English and travel readiness are essential.

Qualifications

• Minimum 2+ years of prior CRA experience
• Fluent English with strong spoken and written communication
• Ability to travel up to 75-80% (2-3 days per week)

Responsibilities

• Oversee clinical trial activities at investigational sites with a focus on Site initiation visits (SIV) with travel
• Conduct and write accurate visit reports per SOPs and GCP
• Interact with study investigators and coordinators per protocols
• Ensure SDV between sites and source documents
• Collaborate on data reviews and resolve queries with sponsor
• Monitor completion of action items between visits
• Prepare for audits and inspections
• Review informed consent forms and study protocols

Skills

CRA experience

Fluent English

Education

B.A./B.S. or equivalent in health/science

Job description

Avania is hiring Clinical Research Associates II (CRA II) - Medical Device Clinical Trials

Minimum 2+ years of prior CRA experience needed (Including SIV experience)

Cardiovascular experience needed

**Ideal: West Coast or the Midwest

Avania’s Clinical Research Associate II (CRA II) establishes, maintains and supports clinical trials. Through the monitoring process, you will verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Further, you will ensure that the conduct of the trial follows approved protocols/amendment(s), with ISO14155 or ICH-GCP, and with applicable regulatory requirements.

Your role will include -

Clinical Trial Monitoring:

• Oversee clinical trial activities at investigational sites with a focus on Site initiation visits - SIV (will require travel to investigational sites)
• Conduct and write accurate visit reports in accordance with SOPs and GCP, including pre-study, site initiation, routine monitoring, and close-out visits.
• Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols
• Ensure data entered on the CRFs by investigational sites is performed in a timely manner and verify that data is consistent with patient clinical notes, known as source data/document verification (SDV)
• Collaborate with analytical services as appropriate, to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data
• Monitor sites' completion of action items between visits

Study-Specific Documents and Files:

• Prepare for audits and inspections
• Participate in internal TMF reviews
• Review and write informed consent forms
• Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development

Regulatory Affairs:

• Prepare submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and assist in administrative tasks for submissions
• Prepare confidentiality agreements and complete templates of clinical trial/investigator agreements
• Prepare annual trial progress reports for IRBs/ECs and CAs/FDA under supervision
• (Assist in) reporting Serious Adverse Event to Sponsor, IRBs/ECs, CAs/FDA and investigators

Additional Responsibilities:

• Participate in project meetings and investigator meetings; write and publish minutes
• Perform submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and follow-up until approval is obtained.
• Prepare clinical trial agreements and discuss/negotiate between site and Sponsor

Skills & Other Requirements

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply. With our continued growth we are hiring talent to join us on our journey and grow with us.

CRA IIs require skills in planning and preparation; sourcing and collecting information; prioritizing tasks and actions; and displaying a proactive attitude to assist in project planning and study execution.

We seek -

• B.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience
• Minimum 2+ years of prior CRA experience needed
• Previous experience with medical device or medical technology studies strongly preferred
• Ability to understand basic and complex medical details
• GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable; knowledge of regulatory regulations and guidelines on medical devices
• Excellent planning and prioritizing skills with a strong client focus and the ability to flex with business needs. Results-oriented
• Ability to travel up to 75-80% (includes overnight travel - on average, will travel 2-3 days per week, with up to 8 site visits per month)
• Fluent English, good spoken and written communication skills

We offer -

• The opportunity to work in an innovative, fast-growing and rewarding industry
• A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties
• Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities
• Competitive compensation and benefits package (details shared during the interview process)
• Some roles offer the opportunities for travel

We look forward to receiving your application!

Salary range $90,000 - $110,000 + Annual performance related bonus + Benefits -

Avania takes pride in being an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.