This CRC II position is fully on-site at our site in Springville, Utah with some travel to the American Fork site boosting exposure across teams, studies and therapeutic areas!

Overview:

This individual will play a key role in leading 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 CRC II should be a very autonomous worker that requires little supervision and has a willingness to take on responsibilities and to be accountable for those responsibilities.

Study Coordination and Protocol Management

• Coordinate as primary CRC on at least 4-6 studies of medium to high complexity with minimal oversight.

• Read and be familiar with all aspects of the study protocol in several therapeutic areas.

• Determine which data is reportable and specified per the Study Protocol and review data in Subject charts for content and completeness.

• Clarify data queries in Source Documents, eCRF’s, and Regulatory Binders.

• Maintain, update, and regularly upload electronic Study Logs for all.

• Assist with Sponsor, FDA, and IRB audits as needed.

• Comply with Avacare and Sponsor policies, standard operating procedures (SOPs), and guidelines.

Communication and Team Collaboration

• Provide proactive and professional communication between on/off-site Investigators, Sponsors, Research Coordinators, Subjects, Monitors, IRB, and vendors in all facets of the study.

• Mentor less experienced staff. Set a positive example and encourage growth of all team members.

• Provide quality assurance checks for other team members.

Patient Interaction and Safety

• Develop and implement patient recruitment strategies; actively recruit to ensure enrollment targets are achieved.

• Support the safety of research subjects and report adverse events.

• Perform blood draws if applicable and complete the processing and shipment of blood samples, collect and record vital signs, conduct ECGs and obtain printouts, urinalysis, Drug Accountability, and regulated storage of Investigational Drug(s) and blood samples according to protocol.

• Collect, process, and ship laboratory specimens.

• Manage inventory and administer test articles/investigational product to participants.

Study Visits and Procedures

• Coordinate protocol-related research procedures, study visits, and follow-up.

• Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities.

Adaptability and Initiative

• Display adaptability by adjusting readily to changes in job assignments, methods, personnel, or surroundings.

• Show initiative and resourcefulness by noticing projects to be done and then taking appropriate action to complete them.

• Must be able to differentiate priorities and be able to change direction of study action as the need arises.

Additional Responsibilities

• May be asked to perform special project responsibilities and travel to other clinic locations, within the area, when needs arise.

• Perform other duties as assigned.

Qualifications:

• GCP/ICH Knowledge: Proficient in applying GCP/ICH and regulatory guidelines.

• Experience: Minimum of 3 years as a Clinical Research Coordinator in a clinical investigative site.

• Clinical Skills: Experienced in obtaining vitals, phlebotomy, EKG, etc.

• Site Operations: Knowledgeable in site operations and the drug development process.

• Communication: Strong communication skills.

• Computer Proficiency: Skilled in Microsoft Word and Excel.

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 $43,500.00 - $72,500.00. 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.