The Clinical Trial Coordinator is involved in the various aspects of managing and administering of clinical trials under the direct supervision of the Clinical Trial Program Manager. The ideal candidate will have experience in clinical research, preferably in the field of orthopaedics.
Location: Vail, CO.
Assists with 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 post-award activities.
Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures.
Coordinates with Principal Investigator, study teams and administration to help ensure that clinical research and related activities are performed in accordance with federal regulations, institutional and sponsoring agency policies and procedures.
Assists in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Conducts trainings and maintains documentation of training.
Prepares other study materials including, but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, IRB submissions, and drug accountability logs.
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Collects data as required by the protocol. Assures timely completion of Case Report Forms.
Maintains study timelines.
Assists to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
Assists with monitoring clinical trial activities to ensure project goals and objectives are achieved and deliverables are on time and within budget.
Participates in day to day activities such as informed consent process, scheduling and screening, as applicable.
Works with the Investigators and study teams to manage the day to day activities of the study including problem solving, communication and protocol management.
Follows policies and procedures established in the SPRI Employee Handbook; adhere to SPRI safety policies.
Maintains a professional commitment to the Steadman Philippon Research Institute mission and values.
Attributes and Qualifications:
Bachelor of Science degree in a relevant science or medical discipline required. Nursing degree or RN preferred.
2+ years of relevant experience in clinical research.
Active CRC (from ACRP) or CCRP (from SOCRA) accreditation preferred.
Strong written and verbal communication, interpersonal, analytical and problem-solving skills.
Proven organizational skills; ability to manage multiple priorities and work under pressure.
Knowledge of clinical study and drug development processes and GCP/ICH guidelines.
Attention to detail required.
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.
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.