Clinical Research Associate
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NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.
NewLink Genetics is looking for experienced Clinical Research Associates (CRA) to work on exciting oncology clinical trials. The CRA will monitor activities at our clinical study sites to assure adherence to federal regulations, good clinical practices (GCPs), standards of procedures (SOPs), and study protocols.
Meet with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, confirm the appropriateness of the IRB and ensure that all documentation required to initiate the study is complete
Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits as directed by the department. On-site monitoring includes: source document verification, ensuring adherence to clinical trial protocol, making sure data is recorded accurately, reviewing regulatory documents, performing study drug accountability, and monitoring and reviewing storage of study drug
Monitor and track patient enrollment and study progress
Prepare site visit reports and other reports as requested by NewLink Management
Maintain regular correspondence with site through email or telephone
Ensure the timely, accurate and complete collection and submission of study data
Identify, address, and resolve issues and problems at the clinical site as they might occur
Maintain site-related files and databases
Assist in distributing and tracking regulatory documents
Collect documents including enrollment logs, site personnel logs, signed protocols, signed amendments, 1572 s, CVs, etc.
Assist in revising and implementing company s clinical SOPs
Assist Clinical Operations in problem solving and provide consultation on monitoring and study related activities
Train and mentor junior staff