Clinical Research Associate II

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

Benefits offered by this job

Annual performance bonus

Benefits package

Job summary

Avania LLC. is hiring a Clinical Research Associate II (CRA II) based in PA, MD, or New York. The role involves monitoring trials, ensuring patient rights and data integrity, and compliance with ISO14155/ICH-GCP and regulatory requirements.

You will oversee site visits, write reports, guide investigators, perform SDV, and collaborate with analytics to maintain clean data. Travel to investigational sites is required, with responsibilities spanning audits and submissions to IRBs/ECs.

Qualifications

• Minimum 2+ years of CRA experience required.
• Based in PA, MD, or New York.
• Knowledge of ISO14155 or ICH-GCP is preferred.

Responsibilities

• Oversee clinical trial activities at investigational sites with travel to sites.
• Write accurate visit reports in accordance with SOPs and GCP.
• Guide investigators and study coordinators per study protocols.
• Verify data against source documents (SDV) and ensure timely data entry.
• Collaborate with analytics to obtain clean databases and address queries.
• Monitor completion of action items between visits.
• Prepare for audits and internal reviews.
• Assist in submission-related activities to IRBs/ECs and regulatory authorities.

Skills

CRA experience

Travel willingness

GCP/ICH knowledge

Regulatory knowledge

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-SpecificDocuments 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