Skills Required

Clinical Research Project Management, Cardiovascular Clinical Trials, GCP, ICH, Monitoring

Job Description

Clinical Research Project Manager - Academic Research Organization

We are a Denver based Academic Research Organization (ARO) that provides services that support
every aspect of clinical research, including study design, comprehensive trial management,
specialized endpoint evaluation services, and completion of final study reports. Biostatistics
and data management are part of the core capabilities that make us a full service ARO.

Responsibilities:
* Serve as the primary point of contact for industry sponsored clinical trials, as well as any
additional assigned projects.
* Develop and manage multidisciplinary project team members related to project management
activities.
* Schedule, plan for, and document regularly scheduled project team meetings. Assess project
issues, propose resolutions to the project team, company executives and/or the Sponsor, and
then track implementation of resolution through to completion.
* Define and monitor project scope, timelines and deliverables from project initiation to close
out. * Assist in study site selection, initiation and monitoring as required by project.
Provide drug tracking and disposition as needed as required by project.
* Ensure the overall quality of project services and deliverables.
* Participate in the design, writing and review of all project-related documents including:
budgets and proposals, change orders, and study content documents including protocols, case
report forms, statistical analysis plans, study reports and monitoring documents.
* Provide status reports on all projects as necessary.
* Assist in IRB issues.
* Track and request study site payments.
* Provide necessary updates and reports to the Sponsor as outlined by the contract.

Qualifications:
* BA/BS in a scientific field.
* 5+ years experience in clinical research with 2+ years of clinical research project
management experience.
* Thorough knowledge of the Good Clinical Practice (GCP) guidelines and the applicable FDA and
ICH regulations for conducting clinical drug trials.
* Experience with MS Office including Access, Word and Excel.
* Excellent interpersonal communication skills, organizational skills and a great attention to
detail are required. This individual must be able to work as a member of a team and possess
good problem solving skills.
* Possesses the ability to organize, instruct and supervise staff, while promoting group effort
and achievement.
* Ability to manage conflicts and resolve problems effectively.
* Ability and willingness to travel up to 25%.

Location: Denver, Colorado; Boulder, Colorado

Looking forward to receiving your resume through our website and going over the position with
you. Clicking apply is the best way to apply, but you may also:

Email your resume in Word to:

[email protected]
**Please do NOT change the email subject line in any way. You must keep the JobID: CC MonsterAp
: DW-CO-CPM -- in the email subject line for your application to be considered.***

David Wright - Senior Recruiter - CyberScientific