Clinical Site Manager: Enrollment & Operations Lead

Socket.dev; Bountiful (UT); On-site; USD 65,000 - 162,000; Full time

Job summary

IQVIA in the United States seeks an experienced Clinical Research Coordinator to oversee site operations, staff training, and study execution across multiple protocols. The role emphasizes enrollment strategy, protocol adherence, and cross-functional collaboration to meet study objectives.

The position calls for strong GCP/ICH knowledge, leadership, and project management skills, with possible travel to IQVIA sites. Equal opportunity employer statements apply.

Qualifications

• Must have clinical skills experience with patients to obtain vitals and perform procedures such as blood draws, EKG, etc.
• Must demonstrate the ability to fulfill responsibilities of CRC Level II
• Extensive knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Superior knowledge and experience of site operations and the drug development process
• Trained in leadership, project management and process development

Responsibilities

• Oversees the conduct of their assigned site; responsible for the training of staff/providers, process development, point of contact for the Directors of Operations and cross-functional teams
• Works closely with Business Development and Feasibility on study placement
• Accountable for enrollment success at sites across all studies; works to understand revenue expectations
• Develops and implements patient recruitment strategies; actively recruits to ensure enrollment targets are achieved
• Maintains significant depth of knowledge and experience in coordinating across multiple therapeutic areas
• Ability to coordinate as primary CRC on at least 6 studies of medium to high complexity, as well as back-up CRC on other studies when needed
• Conducts 1:1 meetings and annual reviews with site staff
• Assists in the development of the annual site roadmap
• Completes all protocol related training
• Performs quality control checks on source documentation and regulatory
• Works closely with Quality Assurance Department to ensure quality at site; creates processes and CAPAs to improve trends
• Performs patient/research participant scheduling
• Collects patient/research participant history
• Collects and maintains source documentation
• Performs data entry and query resolution
• Supports the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging and laboratory handling manuals, etc.)
• Adheres to an IRB approved protocol
• Obtains informed consent of research subjects
• Supports the safety of research subjects, report adverse events.
• Coordinates protocol related research procedures, study visits, and follow-up
• Facilitates site qualification, study initiation, and monitoring visits, and study close-out activities
• Ensures proper collection, processing, and shipping of laboratory specimens
• Attends training(s) on leadership, communication, and other topics to help in the management of teams, as required
• May be asked to perform special project responsibilities and travel to other CCT locations when needs arise
• Complies with IQVIA, CCT, Clinic, and Sponsor policies, SOPs and guidelines
• Performs other duties as assigned

Skills

Clinical skills

CRC Level II

GCP/ICH knowledge

Site operations

Leadership training

Project management

Job description

IQVIA in the United States seeks an experienced Clinical Research Coordinator to oversee site operations, staff training, and study execution across multiple protocols. The role emphasizes enrollment strategy, protocol adherence, and cross-functional collaboration to meet study objectives.

The position calls for strong GCP/ICH knowledge, leadership, and project management skills, with possible travel to IQVIA sites. Equal opportunity employer statements apply.