POSITION TITLE: Project Coordinator (US)
REPORTS TO : Manager, Project Coordination (US) or Lead Sr. Project Coordinator (US)
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 a project specific training matrix. Communicates with training department to ensure matrix is uploaded into LMS.
· Responsible for the electronic distribution of expedited safety reports, tracking the sent date in CTMS, and filing the project specific email electronically in the Outlook site public folder for the study as well as a hard copy of the email is to be sent to the Novella Clinical Central File Room.
· Responsible for providing projected metrics for Project Coordination billable hours throughout the course of assigned trials to the project Financial Analyst. Provides justifications for overages in Project Coordination billable time.
· Responsible for initiating collection of investigator site end user satisfaction information through an Investigative Site Satisfaction Survey, as applicable.
· Responsible for printing and forwarding project master file documents to the Novella Clinical Central File Room to ensure the project master file is current, complete, and audit ready. Assists Project Manager with quarterly project master file audit 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 notes for Project Review Meetings, post-study review 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 preferred
· 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
Novella Clinical - 12 months ago