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Job Details

Clinical Research Engineer Study Coordinator

Company name
MTF Biologics

Location
Edison, NJ

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Job Description
Overview/Risks\r\r\r\r\r\r\r\r\r\rThe Clinical Research Engineer 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.\r\r\r\r\r\r\r\r\r\r\r\r\r\rResponsibilities\r\r\r\r\r\r\r\r\r\rPlan, design, and implement human clinical study protocols based on the needs of the organization to evaluate or support new tissue forms or devicesMonitor clinical studies and collect and analyze clinical data for report and/or presentations to internal teams and senior leadership, as well as surgeonsCreates and/or manages clinical data management systems and electronic data capture systemsIs responsible for on-site monitoring of U.S. study site data up to 20% of the timePrepares post-monitoring audit and corrective action reportsDevelops case report forms (CRFs) and prepares study binders as neededInvestigates serious adverse event reports (SAEs) according to protocol and within regulatory requirements. Maintains an adverse event database for each study.Prepares and resolves CRF queries in collaboration with study site personnelDesigns, obtains, processes and reviews for appropriateness, regulatory and Investigational Review Board documents.Collaborates on investigator’s brochures, patient consents, letters of agreement and confidentiality documentsOther duties as assigned(exempt)(non-exempt)\r\r\r\r\r\r\r\r\r\r

Job Requirements
\r\r\r\r\r\r\rMINIMUM QUALIFICATIONSEducation:  Bachelor's Degree in a technical discipline (e.g. Engineering or Life Sciences) required.Years of Experience:  3 - 5 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 experience of 3 years 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 4. Minimum experience of 2 years in study site monitoring for a tissue, pharmaceutical, biotech or device company or CRO                                  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 and 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. Ability to handle multiple projects simultaneously Flexibility and ability to adapt to changing scope of workAble to propose thoughtful solutions to challenges, issues, and proactively implement solutions with minimal guidance PREFERRED QUALIFICATIONSEducation:  Master's Degree or Ph.D. strongly preferred.Experience:   Execution of a clinical study related to tissue, medical device, or pharmaceuticsSpecific Licenses and/or Certifications: CCRP preferredSpecialized Knowledge, Technical Skills, and Abilities:Insert a bulleted list of work experience and skills needed to perform the job; see guide for a list of sample skills and abilities.   WORKING CONDITIONSOffice 80% of the time with travel within the United States 20% of the time

Company info

MTF Biologics

Company Profile

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