Senior Clinical Research Coordinator

ALLIANCE CLINICAL LLC • Irving, TX

122d

About The Position

This position requires 60% travel and involves partnering with the Regional Site Director to ensure compliance and productivity of all clinical site staff and operations. The role includes managing, training, and supporting clinical site staff, reviewing and communicating study protocols, and overseeing Site Initiation Visits (SIV), Pre-Study Validation Visits (PSV), and Interim Monitoring Visits (IMV). The individual will assist the Clinical Research Coordinator (CRC) team as needed to facilitate research and business needs, conduct and manage clinical trials in accordance with study protocol guidelines and internal Standard Operating Procedures (SOPs), and ensure all data is entered into the sponsor’s data portal with timely resolution of queries. Additionally, the role involves working closely with Contract Research Organizations (CROs), Clinical Research Associates (CRAs), and Institutional Review Boards (IRBs), performing administrative tasks such as ordering supplies and equipment for the study, and managing all required study start-up documentation, training, and timelines on assigned study protocols.

Requirements

• Associate’s degree and/or completion of accredited healthcare certification program, required.
• Comfortable stepping into a leadership role.
• 2+ years’ experience in clinical research, required.
• 2+ years’ experience working as a Clinical Research Coordinator, preferred.
• Comprehensive knowledge of FDA, GCP & confidentiality.
• Exceptional attention to detail and organization.
• Excellent written and communication skills.
• A proven ability to multi-task in a rapidly changing environment.

Responsibilities

• Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations.
• Manage, train and support clinical site staff.
• Review, comprehend and communicate study protocols.
• Oversee Site Initiation Visit (SIV), Pre-Study Validation Visit (PSV) and Interim Monitoring Visit (IMV).
• Assist CRC team as requested to facilitate research and business needs.
• Conduct and manage clinical trials in accordance with the study protocol guidelines and internal SOP’s.
• Ensure all data is entered into sponsor’s data portal and all queries are resolved in a timely manner.
• Work closely with CRO/CRA and IRB.
• Perform administrative tasks such as ordering supplies and equipment for the study.
• Manage all required study start up documentation, training and timelines on assigned study protocols.

Benefits

• 401 (k) Retirement Plan
• Medical, Dental, and Vision Insurance
• Paid Time Off (PTO)
• Floating Holidays
• And more!

What This Job Offers

• Education Level: Associate degree