Clinical Research Coordinator

Job Description:
Responsibilities The CRC is responsible for, and critically important to the overall operational management of clinical research activities.
The CRC has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository.
Essential to this role is a close collaboration with the Principal Investigator (PI) of each study, to faciliate timely study progress reporting to the PI and enabling appropriate PI oversight, study management, including development of source worksheets and documents, safe and accurate completion of protocol required procedures in accordnace with standard operating procedures, governing regulations and study documents, and perform drug accountablity, patient management, including recruitement, patient interfacing, enrollment, and scheduling, regulatory management, including maintenance of approvals for and timely reporting to the IRB and Consent Form updates.
The CRC works with Principal Investigators, Sub-Investigators, support staff, federal and state agencies, industry partners, and other collaborative departments to coordinate and manage investigator-initiated and sponsor-initiated clinical trials and research endeavors.
This includes the responsibility for research assessment and patient intervention under the supervision of the Principal Investigator.
The CRC drives processes to ensure that studies meet institutional operational research objectives as well as ethical obligations to research participants.
In addition, the CRC is expected to manage other research related projects, as assigned, and is expected to solve potential challenges collaboratively and with professionalism and determination.
Qualifications A bachelor's degree in Science or related fields is strongly preferred.
Demonstrated working knowledge of current medical terminology to accurately read entries in patient charts and record accurately and timely, information into study records and other appropriate research data forms.
Clinical research experience, with in depth knowledge of respective therapeutic area as it pertains to clinical trials and studies.
Demonstrated knowledge of good clinical practices for clinical research as defined by ICH and FDA.
Demonstrated organizational skills to efficiently and effectively provide data management/monitoring support for multiple clinical trials and projects, providing accurate information in a timely manner.
Demonstrated understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information.
Demonstrated ability to prioritize workload to meet demands of PI's, Sponsor and FDA.
Demonstrated knowledge of all components of the research process as it pertains to clinical trials and studies, i.
, IRB procedures and processes, data management, , etc.
Demonstrated interpersonal skills to work with patients, their families/ guardians, physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
Ability to understand that work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner.
Notify direct supervisor of any conflicts in demand on time or priorities.
Computer skills using PC platform computers with proficiency in Excel, Word, FileMaker pro to enter data and generate correspondence accurately.
Demonstrated English writing skills to generate original correspondence, including reports, using correct grammar, syntax and punctuation.
Demonstrated English verbal skills to obtain and convey accurate information, explaining research protocol to patients and other staff.
Ability to work at more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings.

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