Senior Clinical Research Specialist

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⛷️ Utah – Remote

⛷️ Utah – Remote

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Merit Medical Oncology

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1987

🤝 B2B

💰 $4.2M Venture Round - Cianna Medical on 2016-10

B2B

Merit Medical Oncology is a division/specialty of Merit Medical Systems focused on devices and procedural solutions for oncologic interventions. It is part of Merit Medical Systems, a global manufacturer founded in 1987 that designs and markets proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures across cardiology, radiology, oncology, critical care and endoscopy. Merit Medical Oncology supports hospitals and physicians worldwide with products (e. g. , biopsy, embolotherapy, drainage, and other oncology-related interventional tools), clinician education and training, regulatory and product documentation, and global distribution and customer support.

📋 Description

• Sets up and maintains trial master file and is responsible for filing and maintaining up to date study documents. • Maintains multiple trackers following the progress of assigned clinical trials, such as essential documents, investigational product, trial supplies and study follow-up visits, as applicable. • Orders, prepares, and sends documents and materials to clinical trial sites and vendors as needed (electronic and paper). • Provides support to study vendors. • Collects and reviews all regulatory documents for accuracy and compliance to departmental SOPs, local and national regulations and guidelines. • Follows up as required to resolve deficiencies. • Ensures that regulatory documents are maintained and updated in a timely and appropriate manner. • Ensures study team training records are kept current. • Performs in-house duties to assist monitors, e.g., outstanding action items. • Manages central IRB submissions and supports sites in IRB/EC submissions. • May attend site visits to assist monitors, when applicable. • Assists with the development of study and site tools. • Contributes to clinical site interactions, including enrollment and subject visit updates, clinical trial material and clinical supply requests, issue resolution, etc. • Assists in developing and overseeing study operational plan(s) as applicable (e.g., TMF plan). • Contributes to study team for trial start-up, conduct, and close-out activities according to industry and departmental standards. • Conducts study systems training(s). • Contributes to creation of study documentation including informed consent, newsletters, etc. • Provides general support to the Clinical Affairs team and project team(s), including meeting agendas, minutes and management of translations. • Assists Project Managers with invoice receipt and review as applicable. • Performs other duties and tasks, as required.

🎯 Requirements

• Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification • A minimum of six (6) years of related work experience • Current Good Clinical Practice (GCP) certification • Knowledge of US regulations, Good Clinical Practice and ICH guidelines • Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs • Clinical trial experience.

🏖️ Benefits

• Medical/Dental & Other Insurances (eligible the first of month after 30 days) • Low Cost Onsite Medical Clinic • Two (2) Onsite Cafeterias • Employee Garden | Gardening Classes • 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays • 401K | Health Savings Account