This is an on-site position located in Lakewood, Colorado

Job Overview

This individual will play a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. The employee, working closely with study team members, will achieve study objectives and corporate goals. 

Essential Functions

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, standard operating procedures (SOPs) and guidelines

Performs other duties as assigned

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $62,400.00 - $156,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.