The Steadman Philippon Research Institute 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.
 
Our perspective is based on clinical relevance, with a goal of improving the care of the patient. Recognizing that the body's innate healing powers can be harnessed and manipulated to improve the healing process has led to exciting advances in surgical techniques.
 
Building on our legacy of excellence in orthopaedic sports medicine, SPRI is unlocking the secrets of healing, finding cures and enhancing lives through global leadership in regenerative medicine, scientific research, innovation and education.

Positions Available

If you are interested in working in a dynamic environment where our research into the causes, prevention and treatment of orthopaedic disorders are known throughout the world, please submit your resume and cover letter to jobs@sprivail.org.

Clinical Trial Program Manager

The Clinical Trial Program Manager will be responsible for the planning, management, execution and completion of clinical trials in support of receiving federal and private sector grants and fulfilling grant related obligations.

CLASSIFICATION:  This is a full-time, exempt position with benefits.

JOB RESPONSIBILITIES:

  • Manage the planning and execution of clinical trials including the design and preparation of clinical trial protocols, study manuals, project-specific plan development, study timelines and other post-award activities.
  • Manage collaboration with all principal investigators and other key clinical staff members to implement processes and structures for conducting clinical trials by institutional guidelines.
  • Act as primary contact for sponsor representatives, vendors and third-party providers and collaborate on scope of work and project activities to ensure deliverables are completed on time and key performance indicators are monitored.
  • Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures.
  • Provide input and expertise for the development of clinical documents including protocols, case report forms, SOPs, investigator brochures, study manuals, study plans and IRB materials.
  • Facilitate the development and management of study budgets.
  • Anticipate complex study obstacles and implement solutions to achieve project goals.
  • Monitor and manage clinical trial activities to ensure project goals and objectives are achieved and deliverables are on time and within budget.
  • Prepare and review metrics and key performance indicators and provide suggestions that contribute to process improvements in support of departmental and organizational goals.
  • Manage external resources as required.
  • May be responsible for mentoring junior research staff.
  • Follow policies and procedures established in the SPRI Employee Handbook; adhere to SPRI safety policies.
  • Maintain a professional commitment to the Steadman Philippon Research Institute mission and values.

KNOWLEDGE, EXPERIENCE AND SKILL REQUIREMENTS:

  • Bachelor of Science degree in a relevant science or medical discipline required. Master’s degree preferred.
  • 5+ years of relevant experience in clinical trial management required, prefer experience working with the DoD, NIH and other government grant agencies.
  • Active CRC (from ACRP) or CCRP (from SOCRA) accreditation preferred.
  • Strong written and verbal communication, interpersonal, analytical and problem-solving skills.
  • Good presentation skills: ability to present to diverse groups of clinical staff (internal and external).
  • Proven organizational skills; ability to manage multiple priorities and work under pressure.
  • Extensive knowledge of clinical study and drug development process, GCP/ICH guidelines and SOPs.
  • Attention to detail required.
  • Ability to develop SOPs, demonstrate regulatory compliance, and implement strong quality processes.
  • Demonstrated understanding of medical regulatory requirements and impact on development of clinical trials.
  • Experience with Microsoft Office Suite and metrics software.
  • Successful experience in a fast-pace entrepreneurial non-profit environment.
  • Knowledge basic orthopaedic terminology and human anatomy is preferred.

We are an Equal Opportunity Employer. We are committed to equal treatment of all employees without regard to race, national origin, religion, gender, age, sexual orientation, veteran status, physical or mental disability or other basis protected by law.  

Research Technician

Under the supervision of a senior scientist and/or CRSM director(s), the Research Technician performs skilled, administrative, and managerial support in research. These projects will require learning new techniques, and the Research Technician will help plan and direct certain phases of research projects. The candidate will also operate research equipment, take initiative to learn new techniques, and assist in preparing proposals for funding agencies.

CLASSIFICATION: This is full-time, hourly position with benefits.

JOB RESPONSIBILITIES:

  • Assists in the execution and analysis of experiments in support of various research projects.
  • Selects and apply standard techniques of routine research; maintain detailed data records in lab notebook.
  • Frequently checks in a receives support and direction from CRSM directors/senior staff.
  • Learn to perform data analysis, statistical analysis, and technical evaluation of research experiments and results, with little to no familiarity of software programs (NIS Elements, Photoshop, Image Lab, ImageJ, and Prism).
  • Summarize results for inclusion in scientific abstracts and reviews.
  • Assist in writing proposals to funding agencies or scientific publications.
  • Participates in the maintenance of a clean lab environment; notify Lab Operations Manager when equipment issues arise.
  • Work from developed laboratory SOP and follows safety standards within the laboratory.
  • Assist with reports, invoices, and cataloging invoices.
  • Follow policies and procedures established in the SPRI Employee Handbook; adhere to SPRI and CRSM safety policies.
  • Maintain a personal commitment to the Steadman Philippon Research Institute mission and values.
  • Other duties as assigned.

KNOWLEDGE, EXPERIENCE AND SKILL REQUIREMENTS:

     Technical

  • Bachelor’s degree in molecular or cellular biology, chemistry, bioengineering, pre-med or a related field or an equivalent combination of education and experience.
  • No formal experience required. Preference is given to those with previous research experience and those familiar with some molecular or biochemical laboratory techniques and software analysis programs.
  • Demonstrates knowledge and understanding of disease pathways and disease-related biological targets.

     Administrative

  • Has exceptional interpersonal skills and the ability to work with others in a collaborative and flexible manner.
  • Eager to learn new techniques and actively contribute to novel research projects.
  • Must be adaptable to unexpected changes and possess strong organizational, verbal, and technical writing skills.

     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. 

We are an Equal Opportunity Employer.  We are committed to equal treatment of all employees without regard to race, national origin, religion, gender, age, sexual orientation, veteran status, physical or mental disability or other basis protected by law.

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