Clinical Research Manager jobs in Boulder, CO

Description

The Steadman Philippon Research Institute (SPRI) is known throughout the world for our research into the causes, prevention, and treatment of orthopaedic disorders. We are committed to solving orthopaedic problems that limit an individual's ability to maintain an active life. 

Scientists and researchers for the Center for Regenerative and Personalized Medicine (CRPM) are underway on several research projects, including SPRI’s federally funded clinical trials, preclinical projects and research programs sponsored by philanthropy. CRPM is conducting research supported by the National Institutes of Health (NIH), Department of Defense (DoD), industry and foundation grants and awards. The team employs six full-time PhDs and two full-time MDs, five of whom are principal investigators and program directors for CRPM’s research categories. The team is led by Johnny Huard, PhD, who also serves as SPRI’s Chief Scientific Officer.

The Laboratory Operations Manager is responsible for the daily administrative, safety and managerial decisions that impact on the laboratory's operation.

PRIMARY JOB RESPONSIBILITIES:

•  Develop and maintain documentation associated with laboratory quality assurance (QA) and quality control (QC) including: 1) the laboratory QA manual; 2) standard operating procedures (SOPs) for field sampling, laboratory activities such as sample processing, analytical methods, and data analysis/reporting; and 3) software/reports for the analysis and reporting of QC data.
• Manage and implement laboratory QA-related activities, such as conducting instrument calibrations and quality checks, QC sample preparation and analysis, and laboratory performance testing; performing statistical analyses to determine detection/reporting limits and evaluate performance acceptability; undertaking necessary instrument trouble-shooting and corrective actions.
• Maintain proper inventory of clinical research samples and conduct daily administration of the laboratory information system (LIMS).
• Manage inventory of supplies real-time to ensure adequate supplies are on hand to execute science.
• Execute on clinical trials per SOPs and funding agency requirements.
• Maintain and manage cell culture facility, including performing cell expansion, differentiation assays, and banking.
• Train new research staff, including international research scholars and research assistant interns in standard laboratory techniques.
• Mentor and train junior staff, providing troubleshooting in day-to-day laboratory experiments.
• Participate in maintenance of laboratory budget.
• Oversee the maintenance of an organized, clean lab environment.
• Ensure lab equipment is in working order and is properly calibrated.
• Evaluate workflows and turnaround commitments and arrange staffing to meet all targets in a safe and timely manner.
• Ensure compliance with all lab standards, safety regulations, quality standards and productivity measures.
• Participate in laboratory audits.
• Develop laboratory SOPs and ensure safety standards are maintained within the laboratory.
• Prepare, review, proofread and confirm format for submission of abstracts and manuscripts for publication and submit.
• Demonstrate the ability to support growth and expansion in response to new and emerging initiatives and research needs.
• Ability to proactively identify and adapt to new and emerging standards, equipment, and protocols.
• Ensure attention to detail and active supervision across multiple locations.
• Follow policies and procedures established in the SPRI Employee Handbook; adhere to SPRI safety policies.
• Maintain a personal commitment to the Steadman Philippon Research Institute mission and values.

Requirements

Technical

• Bachelor of Science (BS) in molecular biology, biochemistry, or related field.
• Five years of experience in laboratory research, ideally in an industry setting. Strong preference is given to those with experience in orthopaedic-related fields and experience with QA/QC.
• Experience with Current Good Manufacturing Practice (CGMP) regulations, preferred. 
• Proven ability to interpret and explain Food and Drug Administration (FDA) policies and regulations.
• Solid technical ability and hands-on experience with molecular biology, ribonucleic acid ( RNA) and protein analysis, analytical gel electrophoresis, quantitative polymerase chain reaction (qPCR),enzyme-linked immunosorbent assay (ELISA), western blot, flow cytometry, quantitative reverse transaction (qRT-PCR), microscopy, histology, and cell culture.
• Demonstrates knowledge and understanding of disease pathways and disease-related biological targets.
• Extensive cell culture (maintenance and differentiation) and cell-based assay experience.
• Experience maintaining research regulatory documents (SOP, Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), etc.).

 Administrative

• Must be a self-starter and demonstrates creativity and independent judgment.
• Has exceptional interpersonal skills and the ability to work with others in a collaborative and flexible manner.
• Must be adaptable to unexpected changes and possess strong organizational, verbal, and technical writing skills in the English language. 
• Ability to work collaboratively with industry and academic partners.
• Ability to manage and complete multiple projects simultaneously while working under occasionally stressful conditions. 

  General

• Ability to handle confidential/sensitive information and exercise good professional judgment.
• Strong initiative and ability to work effectively under general supervision.
• Translate the organization’s vision and values into day-to-day activities, behaviors, and decisions.
• Ability to represent SPRI in a mature and professional manner.  

SUPERVISOR: Lab Operations Coordinator(s) for all sites.

TYPICAL PHYSICAL DEMANDS:  

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Requires corrected vision and hearing within normal range. 
• Requires standing and walking for certain periods of time.  

Typical Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Typical office conditions.
• Requires working under stressful conditions at times.
• Works with a variety of highly confidential, sensitive materials.
• May lift up to 50 pounds. Over 50 pounds two-person lift and or with other assistance. 

CLASSIFICATION/BENEFITS: Full-time, year-round exempt position with bonus potential. Hiring range $70,000 - $85,000 per year based on qualifications. Benefits offered: health care, dental, vision, employee assistance program, life, and accidental death, supplemental, FAMLI, STD, LTD, 401(k), paid time off plans for personal, paid sick, holidays and bereavement.
 

Applications for this position will be accepted 9 days from the online posting date. If the position is not filled during this time, the application window will be extended until filled. Candidates who are selected to move through the interviewing process will be contacted directly.