Clinical Research Study Coordinator (Hybrid)

The Clinical Research Study Coordinator will be responsible for the planning, development, and implementation of human clinical studies and for the monitoring and reporting of clinical study progress and results at designated clinical study sites.

Plan, design, and implement human clinical study protocols based on the needs of the organization to evaluate or support new tissue forms or devices Monitor clinical studies and collect and analyze clinical data for report and/or presentations to internal teams and senior leadership, as well as surgeons Create and/or manage clinical data management systems and electronic data capture systems Is responsible for on-site monitoring of U.S. study site data up to 20% of the time Prepare post-monitoring audit and corrective action reports Develop case report forms (CRFs) and prepare study binders as needed Investigate serious adverse event reports (SAEs) according to protocol and within regulatory requirements. Maintain an adverse event database for each study. Prepare and resolve CRF queries in collaboration with study site personnel Design, obtain, process and review for appropriateness, regulatory and Investigational Review Board documents. Collaborate on investigator�??s brochures, patient consents, letters of agreement and confidentiality documents Other duties as assigned

Required Education - Bachelors Engineering or Life Sciences Required Experience -3 Years 1. Medical device, pharmaceutical or other GMP-regulated experience required. 2. Experience in designing, implementing, and presenting human clinical research protocols and studies 3. Minimum of 3 years�?? experience in the use and/or management of electronic clinical data management (ECDMS) and/or electronic data capture (EDC) systems or in a clinical research role Required License, Certification & Registration - Specialized Knowledge, Technical Skills, and Abilities - Well-developed organizational and analytical skills Ability to develop and maintain effective, professional working relationships with physicians and other clinical staff & to interact productively with research teams at multiple geographic locations Proven competence in time management, project development, project management, and effective clinical data management in previous positions Excellent verbal and written communication skills Possesses a strong understanding of integrated electronic clinical information systems (i.e.; Red Cap, EPIC, etc) Possesses a thorough knowledge of FDA, ICH and GCP regulatory requirements to assure proper conduct of clinical development programs, especially as related to data handling, adverse event reporting, HIPAA privacy act, etc. Able to handle multiple projects simultaneously Flexibility and ability to adapt to changing scope of work; able to propose thoughtful solutions to challenges, issues, and proactively implement solutions with minimal guidance