Clinical Project Coordinator (Office-Based) - IQIVA Biotech
IQVIA Holdings Inc.
Morrisville, North Carolina
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Provides project related support to the Project Management staff and other project team members from the proposal development through final deliverable
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Responsible for the tracking, measurement, and evaluation of project metrics to implement efficiencies. Suggests recommendations for outliers found in output.
- Works in conjunction with Project Manager to formulate and maintain a project specific training matrix. Communicates with training department to ensure matrix is uploaded into LMS.
- Drives the development, printing, shipping, and tracking of study binders.
- Responsible for coding project specific invoices and submitting for approval
- Responsible for printing and forwarding project master file documents to the IQVIA Biotech Central File Room to ensure the project master file is current, complete, and audit ready. For those projects utilizing an electronic project master file, responsible for emailing project master file documents to the appropriate inbox. Assists Project Manager with project master file audits and formulates recommendations for missing components.
- Collaborates in the design, development, and maintenance of CTMS.
- Participates in user acceptance testing (UAT).
- Updates CTMS operations guide with project specific information.
- Suggests system enhancements to development team.
- Per project requirements, manages protocol deviation tracking, including client evaluation and subsequent documentation. Formulates recommendations to create efficiencies.
- Per project requirements, develops methodology for site training documentation and interfaces with client.
- Per project requirements, develops project specific working practices.
- Maintains support responsibility, including scheduling, managing agenda updates, and meeting minutes for project team meetings and other meetings, as assigned.
- Provides project administrative support including meeting notes documentation, monthly reports, shipping, filing, tracking, and status summarization, as appropriate.
- Participate and assist in the planning and creation of client and investigator meetings and related materials.
- Perform other duties as required.
KNOWLEDGE, SKILLS AND ABILITIES:
- Adequate knowledge of the clinical research process
- Excellent written and verbal communication skills
- Excellent organizational and time management skill
- Experience in a team/matrix environment
- Demonstrated ability to form strong functional relationships, maintain a positive attitude, and ability to interact with all levels of staff to coordinate and execute study activities
- Ability to handle multiple priorities within multiple clinical trials
- Working knowledge of Microsoft Office
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very limited physical effort required to perform normal job duties
- Ability to travel nationally and internationally is preferred
MINIMUM RECRUITMENT STANDARDS:
- AA/BA/BS degree preferred and/or
- Minimum of one (1) years of related experience in a clinical trial setting is required
- Working knowledge of Microsoft Office
- Prior experience with mentoring/training of staff is preferred
- Ability and willingness to travel nationally and internationally is preferred
- Excellent verbal and written communication skills required
- Excellent interpersonal and organizational skills required
- Ability to work independently, prioritize and work in a matrix team environment required
- Computer literacy required
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [email protected] to arrange for such an accommodation.