CRA 1

PURPOSE

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and

good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject

recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project

needs to enhance predictability.

RESPONSIBILITIES

 Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work

and good clinical practice.

 If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work

with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

 Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

 Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to

manage ongoing project expectations and issues.

 Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to

applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking

regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and

data query generation and resolution. May support start-up phase.

 Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by

submitting regular visit reports, generating follow-up letters and other required study documentation.

 Build awareness of features and opportunities of study to site.

 Collaborate and liaise with study team members for project execution support as appropriate.

All responsibilities are essential to job functions unless noted as non-essential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

 Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice

(GCP) and International Conference on Harmonization (ICH) guidelines

 Good therapeutic and protocol knowledge as provided in company training

 Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a lap top computer

 Good written and verbal communication skills including good command of English language

 Good organizational and problem-solving skills

 Effective time management skills

 Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

 Bachelor's degree in a health care or other scientific discipline or educational equivalent and successful completion of a

CRA Trainee Program or 3+ months of on-site monitoring experience; or equivalent combination of education, training

and experience.

PHYSICAL REQUIREMENTS

 Extensive use of telephone and face-to-face communication requiring accurate perception of speech

 Extensive use of keyboard requiring repetitive motion of fingers

 Regular sitting for extended periods of time

 Requires frequent travel to sites

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.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.