Clinical Research Associate Posting for Polaris
Polaris Pharmaceuticals, Inc. is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer.
The company’s lead therapeutic, ADI-PEG 20, is a novel biologic in late stage clinical development. It has been tested in more than twenty clinical trials globally for a wide variety of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia and others.
We are seeking a Clinical Research Associate with oncology experience to monitor and manage clinical sites participating in studies with our lead therapeutic agent. The CRA will be responsible for performing study activities including, but not limited to, monitoring of clinical studies at the site level to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH guidelines, federal regulations and SOPs. We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible and willing to take on additional responsibilities as required.
- Prepare and conduct study initiation, monitoring and closeout visits at clinical study sites to ensure adherence to protocols and standard operation procedures and any applicable project plan in accordance with Good Clinical Practice, FDA /ICH (E6) regulations and guidance
- Serve as the primary liaison with research sites; monitor the day-to-day conduct of the study, and resolve problems associated with the study; provide administrative and logistical support as needed
- Monitor clinical studies to ensure the quality, integrity and completeness of data verified against source documentation both on site and remotely
- Verify the accuracy and completeness of eCRF data against source documents; assures timely and complete data entry into the database
- Interact with the clinical study sites to resolve data queries and/or data entry errors, and obtain additional information on potential serious adverse events
- Responsible for monitoring studies against defined milestones and timelines to assure that all deliverables are met as described in the Monitoring Plan
- Prepare and submit accurate and timely monitoring reports
- Review, track and manage study documents for completeness and accuracy (clinical reports, Serious Adverse Events, review case report forms for accuracy and completeness as well as query resolution, study supplies, study drug shipments, and enrollment logs)
- Manage key study parameters including, but not limited to, study start-up activities, supplies preparation, data collection, and close-out
- Assist with the collection, review and tracking of site-specific study/essential documents
- Assist the Contract Research Organization/Vendor as needed to resolve queries, etc.
- Maintain and track clinical research progress and provide status update reports
- Participate in the development and review of Case Report Forms, edit checks, and may participate in User Acceptance Testing for electronic database systems used in Clinical Research
- Assists in improving and maintaining department SOPs
- Review clinical site regulatory documents to ensure completeness and retrieve documents for the eTrial Master File
- Maintain the clinical trial master file (eTMF) for all clinical sites
- Perform eTMF reconciliation for all sites to determine status of TMF documents and address missing items
- Perform ongoing reconciliation of the TMF with content from site files on a quarterly basis
- Oversight for all study close-out activities and transfer of Clinical Trial Master Files into archives
- Provide training to site staff and/or other personnel, as required
- Other duties as assigned
- Up to 50% travel may be required at times
- Bachelor’s degree, health related (e.g. science, healthcare, nursing) preferred
- Site monitoring experience in the biotech/medical diagnostics/pharmaceutical industry, CRO or in a hospital setting with at least 2 years of oncology experience
- Strong knowledge of applicable clinical research regulatory requirements including Good Clinical Practice and International Conference on Harmonization guidelines
- Demonstrated core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
- Excellent written and verbal communication skills, interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player
Polaris Pharmaceuticals, Inc. does not discriminate in employment opportunities or practices on the basis of race, color, gender, religion, veteran and military status, marital or registered domestic partner status, age, national origin or ancestry, disability, medical condition (including genetic information or characteristics), sexual orientation, or any other characteristic protected by federal, state, or local laws.