Details
Posted: 10-May-22
Location: Broomfield, Colorado
Salary: Open
Categories:
Operations
You.
You bring your body, mind, heart and spirit to your work as a Research Manager for the Front Range care sites.
You know when to move quickly. When to sit quietly. When to laugh loudly.
Youâ™re generous with your thoughts, your partnerships and especially your voice, because your opinion matters.
Youâ™re great at what you do, but you want to be part of something even greater. Because you believe that while individuals can be strong, the right team is invincible.
Us.
System Services is our Corporate Headquarters in Broomfield, Colorado and is located within the Oracle campus. SCL Health is a faith-based, nonprofit healthcare organization dedicated to improving the well-being of the people we serve.
Benefits are one of the ways we encourage health for you and your family. Our generous package includes medical, dental and vision coverage. But health is more than a well-working body: it encompasses body, mind and social well-being. To that end, weâ™ve launched a Healthy Living program to address your holistic health. Healthy Living includes financial incentives, digital tools, tobacco cessation, classes, counseling and paid time off. We also offer financial wellness tools and retirement planning.
With this position, you are eligible to participate in the At Risk Compensation (ARC) Plan. This plan enables SCL Health to provide leaders with an additional performance compensation opportunity. The ARC Award opportunities are calculated as a percentage of your base salary. Awards are paid out based on attainment of selected SCL Health Board-approved goals.
We.
Together weâ™ll align mission and careers, values and workplace. Weâ™ll encourage joy and take pride in our integrity.
Weâ™ll laugh at each otherâ™s jokes (even the bad ones). Weâ™ll hello and high five. Weâ™ll celebrate milestones and acknowledge the value of spirituality in healing.
Weâ™re proud of what we know, which includes how much there is to learn.
Your day.
As a Research Manager you need to know how to:
- Oversee day-to-day research coordinator and data management activities.
- Supervise coordinators in on-site monitoring of ongoing studies/projects.
- Work directly with the Regional Director to ensure Research Institute Strategic plans, regional, site and department goals are met.
- Manage, maintain and help to facilitate working relationships with industry client/sponsor/CRO.
- Aid in recruitment of new sponsors/CROs/studies and maintaining a diverse research portfolio.
- Develop and execute various recruitment strategies in order to enhance patient enrolment.
- Serve as an escalation point for data, regulatory, finance and coordinator issues.
- Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development
- Oversee siteâ™s adherence to SOPs, Good Clinical Practice, ICH, and FDA regulations.
- Identify and track trends and opportunities for improvement of clinical trial performance. Develop and maintain dashboards (metrics) of data to track and trend clinical trial activity. Create custom reports to analyze key data and provide performance reports for Research Institute leadership.
- Assist in development or maintenance of Research Institute standard operating procedures, workflows and best practices as needed.
- Proactively identify project specific issues and sets up strategies to handle this efficiently.
Your experience.
We hire people, not resumes. But we also expect excellence, which is why we require:
- Bachelorâ™s degree, required
- Masterâ™s degree, preferred
- Research certification (either SoCRA, ACRP, or RAC) or completion of certification within 1 year of hire, required
- Certified Project Management Professional, preferred
- Seven (7) years of experience in a clinical research setting and three (3) years supervisory/management experience, required
- Working knowledge of GCP, ICH guidelines and FDA regulations, and project management, drug development, client/CRO/Sponsor processes, required
- Experience with Industry Sponsored, NCI sponsored, and Investigator Initiated clinical trials, required
- Knowledge of clinical trial fieldwork monitoring concepts and practices including on site monitoring requirements, FDA and IND regulations, and GCPs, required
Your next move.
Now that you know more about being a Research Manager on our team we hope youâ™ll join us. At SCL Health youâ™ll reaffirm every day how much you love this work, and why you were called to it in the first place.