Clinical Research Associate, Sponsor Dedicated

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. The Clinical Research Associate, Sponsor Dedicated performs site monitoring and management activities, ensuring study sites follow protocols, regulations, guidelines, and sponsor requirements. The role also supports recruitment, regulatory tracking, study documentation, site communication, and study team coordination.

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

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

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

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements

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

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

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

If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Preferred

Bachelor's Degree in scientific discipline or health care preferred

Scientific Degree

Healthcare Degree

Benefits

Incentive plans, bonuses, and/or other forms of compensation may be offered.

A range of health and welfare and/or other benefits may be offered.

Company

Clinical research, commercial insights, and healthcare intelligence for life sciences.

Durham, North Carolina, USA

https://www.iqvia.com/

Founded in 1982

10001+ employees

Qualifications

To be eligible for this position, you must reside in the same country where the job is located

Requires a minimum of 1 year of independent on-site monitoring experience as a Clinical Research Associate (CRA)

Equivalent combination of education, training and experience may be accepted in lieu of degree

Good 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 laptop computer and iPhone and iPad (where applicable)

Written and verbal communication skills including good command of English language

Organizational and problem-solving skills

Effective time and financial management skills

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

Bachelor's Degree in scientific discipline or health care preferred

Requires a minimum of 1 year of independent on-site monitoring experience as a Clinical Research Associate (CRA).

Required skills

Clinical Site Monitoring, Clinical Practice (GCP), International Conference on Harmonization (ICH) Guidelines, Clinical Research Regulatory Requirements, Therapeutic and Protocol Knowledge, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Regulatory Submissions and Approvals, Trial Master File (TMF) Management, Investigator Site File (ISF) Management, Financial Management, Relationship Management

Preferred skills

Written and Verbal Communication

Experience

1+ years