The Clinical Research Associate is responsible for developing, implementing, monitoring, and maintaining clinical studies. Key responsibilities include critical review of subject medical records, source document verification of case report form data, site management, and protection of subject rights.
- Write and/or provide input into the development of Protocols and amendments, Informed consent forms, Study procedures, Case report forms, Monitoring plans and guidelines, Study forms and templates, and other study documents as needed.
- Identify, evaluate, and select potential study sites and investigators.
- Perform study start-up activities, including regulatory document collection, review, and approval, ICF review and approval, Central IRB submissions and facilitation of local IRB submissions. Tracking start-up documents, contract and budget negotiations, and designing study materials.
- Perform initiation activities, including ensuring all documents and required approvals are in place, providing study staff with information and instructions on study conduct, conducting site initiation meetings via phone or on-site in person, accurately responding to site questions and provide timely follow-up to ensure the site is prepared to begin patient recruitment and enrollment.
- Monitoring activities including tracking subject recruitment and enrollment by site, reviewing subject medical records against the case report form to identify data discrepancies, inaccuracies, outliers, etc. Conduct source document verification (SDV) of medical records to corroborate data included in the CRFs; query sites and abstractors appropriately to ensure data integrity, verifying that the rights and well-being of human subjects are protected, ensuring the conduct of the trial is in compliance with the currently approved protocol/amendment, verifying investigator and site staff compliance with the approved protocol and all applicable GCP procedures, documenting monitoring progress in accordance with the monitoring plan.
- Site management responsibilities including monitoring investigator performance and adherence to protocols, addressing enrollment problems and helping sites develop creative recruitment and enrollment strategies, maintaining regular contact via phone, email, and occasional site visits throughout the trial, close study centers upon completion of trial or when otherwise directed.
Education and Experience Requirements:
High school diploma required. Bachelor’s degree in clinical research or a related field preferred. One year of experience as a CRA in an industry setting, on-site monitoring experience, or study coordinator experience required. Thorough understanding of applicable federal regulations and guidelines and ICH GCPs as well as other relevant industry standards required. Experience working with clinical data, good knowledge of medical terminology, Excellent written and verbal communication skills, Good organizational skills are all required.
To apply, please send a cover letter and resume to [email protected] and indicate the job title in the Subject line.