The CPC, located in downtown Denver, Colorado, provides a great environment in which to work.

If you are interested in applying for any of the positions below, please send CV, cover letter and 3 references to Sandy Brinks, Colorado Prevention Center, 789 Sherman, Suite 200, Denver, CO 80203. Fax (303-860-1288) or e-mail (Careers@cpcmed.org ) will be accepted.

Current Openings:

Biostatistician I/II

Associate Director of Research Operations

Project Manager

Clinical Research Associate II or Sr. Clinical Research Associate

Job Title: Biostatistician I/II
Supervisor: Director of Biostatistics & Data Management

Responsibilities:

• Participate as lead biostatistician on project teams.
• Provide leadership in study design and statistical analysis, and communicate with project team members (project manager, data managers, other biostatisticians, clients, regulatory agencies).
• Provide weekly feedback to the Director of Biostatistics & Data Management on the progress of projects.
• Participate in the review of the design and validation of study database software and related database queries.
• Participate in the design, writing and review of study protocols, including the design of studies and sample size/power estimations.
• Write and review statistical analysis plans (SAP).
• Review CRFs for statistical integrity.
• Analyze and manage data in SAS and other statistical packages.
• Develop statistical programs to analyze data.
• Perform and review analysis of data for multiple clinical trials.
• Prepare, review, and submit final study reports, including NDAs.
• Analyze data for, and prepare and review interim study reports, manuscripts, abstracts, and grants.
• Provide general statistical support and consulting services.
• Develop and review statistical standard operating procedures (SOPs).
• Ensure that study protocols, statistical programs, analyses and reports generated within the CPC comply with GCP, FDA, and ICH guidelines and CPC standards.
• Academically participate in the field of biostatistics/clinical trials through membership in related professional organizations, making presentations at professional conferences, and/or submissions to relevant journals.
• Perform other duties as may be required by CPC management

Qualifications:
Master’s or Ph.D. degree in biostatistics or related field, with 2 to 5 years experience in the analysis of data for clinical trials.  Demonstrable programming experience with SAS 9.0 or higher in a Windows environment.  Experience with Microsoft Office (Word, Excel, PowerPoint).

Good knowledge of ICH guidelines, experience with Phase I-III clinical trials and FDA/NDA submissions helpful.  Must possess excellent analytical, organizational, communications, and team skills, and be detail oriented.  Works well with little supervision.

Job Title: Associate Director of Research Operations
Supervisor: Chief Operating Officer

Responsibilities: Supporting the functions and activities of the Colorado Prevention Center (CPC) in organizing and managing clinical research studies, including but not limited to:

• Act as part of the management team for the Research Operation department.
• Oversee training of Clinical Research Associates and/or Project Managers at the CPC.
• Assist in overseeing Clinical Research Associate staff, as well as providing resource information to CRAs in support for their monitoring activities.
• Supervise and evaluate performance of all staff reporting to this position.
•  Participate in assessment of departmental goals with the RO management team.
• Contribute to the achievement of departmental and organizational goals.
• Serve as the primary point of contact for assigned projects. 
• Develop and manage multidisciplinary project team members related to project management activities.  Coordinate and document regularly scheduled project team meetings.  Assess project issues and propose resolutions to the project team, CPC executives and/or the Sponsor.
• Define and monitor project scope, timelines and deliverables from project initiation to close out.  Assist in site selection and monitoring. Provide drug tracking and disposition as needed.  Ensure the overall quality of project services and deliverables. 
• Participate in the design, writing and review of study documents including protocols, CRFs, statistical analysis plans, study reports and monitoring documents. 
• Oversee selection of qualified sites and investigators for participation in research protocols.
• Site support and co-monitoring for multi-center clinical trials according to the CPC standard operation procedures, Good Clinical Practice guidelines and applicable federal, state and local regulations.
• Overseeing collecting and maintaining investigator regulatory documents.
• Overseeing development of study materials including Case Report Forms, Study Procedure Manuals and source documents.
• Provide status reports to the COO 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.
• Additional activities as required.

Qualifications:

To be considered for this position, you must minimally meet the knowledge, skills and abilities listed below.

• BA/BS in a scientific field.
• A minimum of 7 years experience in medical research and previous experience overseeing at least some aspects of clinical trials.
• Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. 
• Experience with MS Office including Project, 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%. 

Job Title: Project Manager
Supervisor: Director, Research Operations

• 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, CPC 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.
• Additional activities as required.
• Supervise and evaluate performance of all staff reporting to this position.

• BA/BS in a scientific field.
• A minimum of 5 years experience in medical research or related field and a minimum of 2 years clinical research project management experience.
• Thorough knowledge of the Good Clinical Practice 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%.

Job Title: Clinical Research Associate II or Senior Clinical Research Associate
Supervisor: TBD

Job Description:

A unique and exciting opportunity to work as a full-time CRA II or Senior CRA. Regional positions will be considered for exceptional candidates.

• Positions involve site support and monitoring for multi-center clinical trials according to standard operation procedures, Good Clinical Practice guidelines and applicable regulations.
• Other responsibilities include specialized endpoint evaluation site visits to ensure appropriate collection of endpoint data.
• Position will also be involved in hands-on training of site staff, CRAs and Sponsors.
• Up to 60% travel.
• Potential for international travel.
• Full benefits package.

• Minimum 3 years experience in clinical trials research and minimum 2 years monitoring experience.
• Experience with health care and training/mentoring skills are a plus.
• Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
• Computer skills to include spreadsheet databases and word-processing.
• Exceptional interpersonal communication skills and organizational skills, and great attention to detail are all required.
• Must be able to work as a member of a team and possess excellent problem solving skills.

Bachelor’s degree, RN, BSN, or an Associate’s Degree with clinical research experience.