Senior Clinical Research Coordinator, On-Site

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

• 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

• Develops and implements patient recruitment strategies; actively recruits to ensure enrollment targets are achieved

• Works effectively with multidisciplinary, ancillary, and inter-professional research teams

• Functions independently, and is able to identify situations where additional support is necessary

• Performs quality control checks on source documentation and regulatory

• Trains other CRCs, research assistants, and other junior staff when required

• Completes all protocol related training 

• 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 

• May be asked to perform special project responsibilities and travel to other CCT locations when needs arise

• Complies with CCT, IQVIA, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines

Qualifications

• Must demonstrate the ability to fulfill responsibilities of CRC Level II 

• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines

• Knowledge and experience of site operations and the drug development process

• Excellent written and verbal communication skills – must be comfortable and effective in communicating with potential study participants from a diverse population

• Interpersonal skills - open to others’ ideas and willing to learn new things; respond well to questions and challenges

• Process improvement – support ideas and theories on process improvement for efficiency and effectiveness

• Computer proficiency in use of Microsoft Word, Excel

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.  https://

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

The potential base pay range for this role, when annualized, is $0.00 - $0.00. 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.