Clinical Trials Associate II (Pediatric Genetics)

Vanderbilt University Medical Center Nashville, TN

About the Job

**JOB DESCRIPTION:** **Clinical Trials** + Data Entry (everything from patients visits, such as, PEG pal 302 work books, work books for 111-202, entering Adverse events and concomitant medications, going through medical records when patients have been admitted to the hospital, picking up meals for patients, etc.) + Calling/Faxing for medical records (hospitals/patients) + Helping with monitoring visits, gathering necessary patient binders they need, answering questions, going through Confirmation Letters and Follow-Up Visit letters, escorting to pharmacy + Email/Send documents with monitors as needed when they are not here + Getting Star panel access for monitors + Filing patient items and regulatory items in binders + Review phones calls and visits for Con-meds and Adverse Events. Ensure all are assessed in a timely manner. + Distribute and gather training forms for all study personnel. Ensure that training is kept up to date for all study personnel + Keep patient binders and regulatory binders up to date for all studies + Put all documents needing Dr. Phillips signature in his box + Help with patient visits days (going to pharmacy to pick up prescriptions, dropping off supplies, making sure source documents are in patient binders, etc.) + Reserve hotel rooms, reserve flights if necessary + Submit Concur reports for hotel rooms, flight etc. + Reimburse patients for travel expenses and weekly study payments + Reserve the CRC for patients; answer messages that come through on the CRC calendar + Make appointments with ECHO, X-ray, and CT if required for studies + Schedule patient visits on Outlook Calendar and invite additional study personnel if needed + Record measurements for BMN 111-901 + Available during patient visits to assist study coordinator and pick-up study drug + Answer queries in Electronic Data Collection system + Help maintain regulatory binders and patient binders (move to new binder if needed, make copies of labs/physical exams, etc.) + Printing off necessary documents from star panel + Attend trainings, or update online trainings when necessary + Bi Weekly clinical trial meetings and prep for meetings + Lab Kit Labeling/Lab Kit Destroying + Document Building (source docs/power points/instructions for how to do tasks) + Making SOPs and review with LeeAnna + Supply Ordering + Help ensure patient orders are accurate by comparing to lab kits + Meet with LeeAnna to review trials + Assist Administrative Officer with invoices for all clinical trials + Review and verify monthly ledgers **UDN (Undiagnosed Diseases Network)** + Assist the Undiagnosed Disease Network(UDN) in tasks such as filing, scanning and mailing medical records back to not accepted patients, update database, organize blue patient charts and assist the Administrative Program Coordinator for the UDN + Assist with billing plans, FACTr, VICTr and IRB submissions + Act as a backup for Pat, if necessary **Office and State** + File and enter results of Tennessee State Newborn Screens, update Genetics Monthly Database and State Quarterly Report + Scan and electronically file documents for ledger review + Enter Concur reports for providers + Enter Travel Authorizations for PI’s upon request + Scan, request medical records for Genetic Counselors + Make MRN numbers, assist with scheduling, if necessary, for Newborn Screen patients + Order office supplies + Submit Pegasus tickets + Monthly Provider Calendar and weekly On-Call list + Check and sort faxes/mail throughout the day + Answer the phone and direct calls as needed + Update Synergy + Assist with Provider Time Away, upon request + Assist Divisional Administrative Assistant Associate's Degree (or equivalent experience) and 2 years experience **Licensure, Certification, and/or Registration (LCR):** **Physical Requirements/Strengths needed & Physical Demands:** **Movement** + Occasional: Sitting: Remaining in seated position + Occasional: Standing: Remaining on one's feet without moving. + Occasional: Walking: Moving about on foot. + Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another + Occasional: Push/Pull: Exerting force to move objects away from or toward. + Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles + Occasional: Reaching below shoulders: Extending arms in any direction below shoulders. + Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands. **Sensory** + Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision. + Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry. + Continuous: Communication: Expressing or exchanging written/verbal/electronic information. **Environmental Conditions** **Job** _Research_ **Organization:** _Pediatric Genetics 104590_ **Title:** _Clinical Trials Associate II (Pediatric Genetics)_ **Location:** _TN-Nashville-Medical Center North (MCN)_ **Requisition ID:** _1712123_