Responsible for evalutaing, planning, implemntation and regulatory documentation of research studies involving human subjects. |
Assist in the acquisition of biospecimens from medical centers, research institutes and collaborators. Serve as the clinical research coordinator at local medical centers when needed. Work closely with collaborating physicians, pathologists and their institution's regulatory staff. Work with physician and clinical staff to ensure biospecimens are collected properly, processed and sent to TGen according to protocol. Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
Implement research studies from initiation stages through the stages of development of documents, SOPs, and tools. Code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis in full HIPAA compliance.
Serve as a contracted service CRC for investigator initiated studies requiring biosamples and annotated data. Works directly with investigators to facilitate appropriate biosample and data collection for research studies. Assist in the development of study forms, questionnaires and the application of research techniques; assist in writing procedures manuals for data collection and coding. Serves as point of contact for each lab processing specimens. Coordinates and tracks the biospecimen as they move through the laboratory and analysis pipeline.
Assist in writing protocols, consent forms and supporting documents for studies when needed. Assist in the preparation of amendments to protocols and/or modifications to study design as appropriate. Assist investigators with identifying studies that are exempt from needing IRB approval and provide assistance to investigators in writing the exemption requests. Assist in reviewing submission of protocols to Institutional Review Board. This includes reviewing and evaluating exempt, minimal risk and greater than minimal risk human research protocols, consent forms, supporting documents, study amendments, adverse event reports, and continuing review reports.
Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and report adverse events; recommend corrective action as appropriate. Identify and communicate important protocol and data management issues to the appropriate parties. Complete annual review of SOP's to ensure everything is up-to-date. Assist with reviewing, updating, maintaining and implementing TGen Research Compliance policies and procedures in compliance with state and federal regulations. Identifies and reports applicable study deviations to the TGen Office of Research Compliance & Quality Management. Assist with annual audits and supplemental review of protocols involving human subject research. Prepare written reports outlining corrective measures where needed for review and approval by the Director of Research Compliance.
Work with physicians to consent subjects. Be point of contact for participant communication and questions. Can communicate study objectives, procedures, benefits and risks.
Serves as a point of contact for inquiries from the TGen Foundation, inquiries from the public or potentially interested study participants.
BA/BS. Preferred from an accredited Nursing Program. May substitute CRC certification and extensive research experience for educational requirements.
Excellent written and verbal skills
3+ Years of Research Coordinator Experience
CCRC or CCRP Preferred
Experience with Vitals and Phlebotomy
Requires excellent interpersonal skills and demonstrated ability to deal effectively and confidentially with difficult situations; and excellent communication skills.. Employee should be familiar with a variety of the field's concepts, practices, and procedures.
TGen - 16 months ago