Regulatory Activities: Submits new protocol, amendments, continuing reviews, AE, deviations, IND, and closure reporting to local or central IRB according to local, state and federal guidelines. Reviews Study Initiation Regulatory Packets for Pharmaceutical Company, Device Manufactures and National Cancer Institute collaborative groups 'Sponsor' specific documents and requirements for completion of standard regulatory items. Maintains, reviews and updates policies and/or standard operating procedures for Parkview Research Center, as necessary. Reads and revises Informed Consent Form and HIPAA Authorization thoroughly to assess for compliance with regulations, compliance with PH & IRB requirements. References Investigator's Brochure (for drug trials) or Report of Prior Investigations/Owner's Manual (for device trials) as needed to complete the IRB Submission Form. Collaborates with Sponsor, IRB, Physician Investigator and clinical coordinator(s) to implement and maintain protocol compliance per FDA, ICH, HHS/OHRP, GCP, IRB guidelines and sponsor SOPs. Maintains and updates regulatory documents including, but not limited to, protocols, patient signed original ICFs.
Contracting/Budgeting: Tracks revenue and applicable costs for associated trials. As directed, reviews, edits and coordinates with legal counsel, contract language without clinical trial sponsors pursuant to compliance with all applicable internal policies and external guidelines; reviews, assesses and negotiates clinical trials with outside sponsors on budgetary line items pursuant to applicable clinical trials, i.e., start-up/close-out expenses, storage expenses, etc.; and in partnership with legal counsel, negotiates with outside sponsors on contract terms and budgetary line items, i.e., structure of contract length, terms of payment, compliance with Parkview policies, local, state and federal guidelines as applicable.
Billing: Ensures research accounts (internal and external studies) meet the requirements of the Centers for Medicare and Medicaid Services (CMS) - Clinical Trial Policy (CTP); ensures there are no double payments with insurance and sponsor or fraudulent activity with research billing; reviews and completes Workqueue accounts within a reasonable amount of time; and adds research codes and/or modifiers, as needed.
Education: Must have Associates degree. Bachelors Degree preferred. Must complete Parkview general orientation and research specific orientation as provided and required.
Licensure/Certification: CITI training completed upon hire. Additional certifications may be required for specific areas.
Experience: Minimum of 10 years of research experience or equivalent. Additional experience required depending on area of specialty and assignment. Must have excellent verbal and written communication skills. Must have knowledge of medical terminology. Must have knowledge of computer skills including Microsoft applications such as Word Excel Outlook and PowerPoint. Must have excellent data management skills and attention to detail. Must demonstrate analytical ability in order to solve problems of moderate complexity. Must demonstrate acceptable interpersonal skills. Must be able to multi-task handle multiple stressors work under time constraints and meet deadlines. Must have good organizational skills. Must be able to lift 25 pounds. Must be open to training required for the range of research studies conducted at Parkview Research Center.