Research Safety Specialist II Job in The Woodlands 77380, Texas Us
Empowering patients starts with you. It starts with the chain of events you initiate when you work on the combined team of McKesson Specialty Care Solutions and US Oncology- a chain that extends across the country uniting a network of community-based cancer clinics and resulting in millions of people getting more from their healthcare.
Across McKesson Specialty Care Solutions and US Oncology, our team affects the full continuum of healthcare - ultimately helping to improve the patient experience at the individual level. Our specialty pharmaceutical programs offer a significant impact for our customers and their businesses. The Distribution Services segment of our company is dedicated to the wholesale distribution of specialty pharmaceuticals - focusing on oncology and other specialty products. Our Specialty Patient Services group provides compliance and adherence programs, as well as reimbursement hotlines, patient assistance and support programs and the managed distribution of pharmaceutical products. Our Specialty Solution Center is the largest single-site call center in healthcare, offering a centralized approach to optimize manufacturer product reimbursement and access. Our US Oncology operations unite one of the nation's largest health-care services network devoted exclusively to cancer treatment and research, and is a pioneer in community-based cancer care. Annually, the united network of more than 9,000 physicians, clinicians, nurses, and administrators delivers integrated cancer care to more than 850,000 cancer patients in community-based clinics located in 41 states.
Position Description
Under general supervision, coordinates the collection, review, and processing of serious adverse events (SAE), Investigator Drug Brochures (IDB), and Investigational New Drug (IND) Safety Reports. Completes submission forms for SAEs and IND Safety Reports and submits to appropriate agencies and investigators. Follows standard operating procedures (SOPs) and pre-established guidelines. Resolves non routine issues in a timely manner.
-Collects SAEs from research trial sites. Reviews documents to ensure accuracy, coding, and event classification are correct as well as the case description is thorough. Contacts research sites to obtain missing information / documentation or clarify discrepancies.
-Upon receipt of Investigator Drug Brochures (IDB), reviews brochure for creation of Risk Lists of known drug adverse events. Identifies current studies utilizing the particular drug and posts IDB to applicable studies.
Performs quality control verification of Risk Lists and updates with new information as applicable. Produces IDB submission letter for Institutional Review Board (IRB) signature.
-Reviews IND safety reports from sponsors for detailed information on reported event(s), suspect drug(s) and causality as reported by investigator and drug manufacturer. Determines the intended responses for these categories and reports the information as such to the appropriate Study Investigator (SI), Principal Investigators (PI) and to the IRB. Facilitates review and oversight of this information by the SI and PIs as mandated in the Food and Drug Administration (FDA) Code of Federal Regulations (CFR).
-Reviews SAE documents and determines if SAE meets the criteria for serious, unexpected (as outlined in the Risk Lists), and causality related. For applicable SAEs, completes the appropriate IRB submission forms.
-Records, codes, and updates SAE and IND documents into the databases. Files documents and maintains central files in accordance with applicable federal/international regulations and standard operating procedures (SOPs).
- Generates, obtains, and coordinates the submission of monthly Toxicity Reports to the SI in order to facilitate SI oversight of SAEs and IND safety reports. Reviews and records study investigator correspondence as well as obtains missing documents / reports, and follows-up on open action items to study investigator.
-Weekly, generates IND submission forms and summary reports for IRB members to review. Monthly, summarizes IND activity results from IRB meetings for Research sites.
-Hosts monitors/auditors during visits responding to and resolving issues pertaining to safety-related documents. Upon notice of pending visit, prepares and presents central study files for review by monitors and/or auditors.
- Performs quality check on Specialist I and new coworkers SAE reports and work. Trains coworkers on SOPs, forms, and software in conjunction with the Manager, Research Safety.
-Other duties as requested or assigned.
Minimum Requirements
College degree in any field of study or Associates degree in a scientific field of study and at least one (1) year safety specialist SAE experience processing a high volume of work with a low number of errors or a High School diploma and two (2) years clinical research work experience. Proficiency with Microsoft Office Word, Excel, and MS Access databases required.
Agency Statement
No agencies please.
Qualifications
Minimum Requirements
College degree in any field of study or Associates degree in a scientific field of study and at least one (1) year safety specialist SAE experience processing a high volume of work with a low number of errors or a High School diploma and two (2) years clinical research work experience. Proficiency with Microsoft Office Word, Excel, and MS Access databases required.
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