Clinical Research Coordinator I – Neurology

Scheduled Hours
40

Position Summary
Position supports the DIAN Trials Unit (DIAN-TU) Clinical Operations team with coordination of investigational product implementation including IXRS and site/central pharmacy-related activities. Will support other areas of study operations and coordination activities for a fast-paced and complex multi-site international clinical trial.

Job Description

Primary Duties & Responsibilities

• Support/provide input to Clinical Operations during the development, review and tracking of documents related to investigational product including, but not limited to, Pharmacy Manual, IXRS design, labeling and packaging design, drug use and forecasting, instructions for use, and training materials. 
• Support DIAN-TU’s communications with CROs and vendors; assist with sourcing of IP-related supplies and materials, and tracking of any IP-related equipment for DIAN-TU trials. Assist with drug reconciliation activities.
• Support tracking and internal metrics of IP-related issues, such as temperature excursions or dosing issues. Support design and maintenance of databases and materials for tracking IP-related topics. Similar responsibilities may be assigned in other areas of trial management as needed.
• Assist with the review and/or preparation of Standard Operating Procedures (SOPs), source documents, QC documents, protocols, work instructions and other manuals as they relate to investigational product. Coordinates tracking of Corrective and Preventive Action forms (CAPAs). Gain proficiency in federal regulations to ensure regulatory compliance (e.g. ICH-GCP). Assists in audit-related activities and organization and proper filing of IP-related documents. Assist/learn study start-up and closing activities. Supports/assists in the development and implementation of drug reconciliation processes. Similar responsibilities may be assigned in other areas of trial operations and coordination as needed.
• Edit and QC of study materials and manuals. Ensures sites have proper materials/forms and coordinate shipping and delivery of supplies as needed. Accesses electronic databases to provide reports on IP-related issues, such as site or stock status reports, shipment status reports, etc. Assists with site and/or DIAN-TU personnel training as needed. Similar responsibilities may be assigned in other areas of trial operations as needed.
• Performs other duties incidental to the work described herein.

Preferred Qualifications

• ICH-GCP proficiency, investigational-product experience in regulated trial environment; knowledge of investigational product accountability practices, and practical experience in SOP or process development related to IP handling.
• Working knowledge of techniques and methodologies used in coordinating clinical research projects with awareness of database management systems, i.e. IXRS and spreadsheets.
• Good understanding of the operational execution of clinical protocols.
• Basic business writing skills required for pharmacy manuals, study forms or instructions for sites, pharmacies, and home health nurses.
• Excellent communication skills (both written and oral). Ability to be clear, direct, and tactful when communicating with multiple sites (national and international), departments, staff, CROs, vendors (e.g. Home Health Nurses), and investigators.
• Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings, etc.).

Required Qualifications

Bachelor’s degree; prior work experience, preferably in clinical research support, is highly preferred; a combination of relevant work and education equaling four years may substitute for this requirement.

Grade
C09

Salary Range
$45,500.00 – $68,400.00 / Annually

The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one’s qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.

Pre-Employment Screening
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.

Benefits Statement
Washington University in St. Louis is committed to providing a comprehensive and competitive benefits package to our employees. Benefits eligibility is subject to employment status, full-time equivalent (FTE) workload, and weekly standard hours. Please visit our website at https://hr.wustl.edu/benefits/ to view a summary of benefits.

EEO/AA Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.

Diversity Statement
Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

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