Clinical Research Associate II

Avania; New York (NY); Hybrid; USD 90,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation

Annual bonus

Benefits package

Travel opportunities

Job summary

Avania is seeking a Clinical Research Associate II (CRA II) based in PA, MD, or New York to monitor trials, protect patient rights, and ensure data integrity according to GCP/ISO standards. The role requires travel to investigational sites and routine monitoring tasks across regional studies.

The ideal candidate has 2+ years of CRA experience, knowledge of regulatory requirements, and fluent English. Avania offers a competitive package with benefits and opportunities for career growth.

Qualifications

• Minimum 2+ years of CRA experience.
• Based in PA, MD or NY to cover regional studies.
• Experience with medical device or medical technology studies preferred.
• GCP-ICH-E6, FDA regulations and ISO 14155/13485 knowledge.
• Fluent English with strong written and spoken communication.

Responsibilities

• Oversee monitoring activities at investigational sites with travel.
• Write visit reports per SOPs and GCP, including site visits.
• Guide investigators and coordinators in conducting trials.
• Verify SDV and data consistency with source documents.
• Collaborate with analytics for data reviews and trend identification.
• Monitor site completion of action items between visits.
• Prepare for audits and TMF reviews.
• Review and write informed consent forms.
• Prepare trial documents for regulatory submissions.

Skills

CRA experience

Regional coverage

Medical device studies

Regulatory knowledge

GCP-ICH compliance

English fluency

Travel-ready

Planning & prioritizing

Data interpretation

Education

B.A./B.S. or equivalent

Job description

Avania is hiring Clinical Research Associates II (CRA II) - Based in PA, MD or New York

Salary range $90,000 - $110,000 + Annual performance related bonus + Benefits - Minimum 2+ years of prior CRA experience needed

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
• Based in either PA,MD or New York to cover regional studies across these regions
• Previous experience with medical device or medical technology studies strongly preferred
• Prior TA experience in either Respiratory and or Cardiovascular studies
• 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
• Ask us about our hybrid and fully remote work opportunities

Avania - MedTech's Trusted Champion

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.