1) The Clinical Research Coordinator 1 (CRC1) is an entry level researcher working with the Principal Investigator (PI) Dr. David Meltzer, Co-Investigator(s) and other study personnel, and under the limited direction of departmental, clinical research director/manager.
2) With supervision and/or guidance, the CRC1 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the OCR to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.
3) Manage, facilitate and monitor the daily activities of multiple moderately complex protocols and performs a variety of duties involved in the collection, compilation, documentation and reporting of data.
4) The CRC1 plays an instrumental role in ensuring compliance with the study protocol, Federal guidelines, local guidelines in accordance with Good Clinical Practices (GCP).
5) Work with regulatory agents, the Institutional Review Board, study participants, department staff, and hospital staff.
6) This position entails all aspects of conducting clinical research: recruiting/interviewing, screening, consenting, enrollment, subject follow-up, completion of case report forms and adverse event reporting.
7) Educate subjects and parents/guardians about study procedures to be performed.
8) Record data in databases, as required, and will perform medical chart reviews.
9) He/she will maintain accurate and complete documentation of signed informed consent form, relevant Institutional Review Board approvals, source documentation, Case Report Forms, drug dispensing logs, and study-related communication.
10) Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence. 11) Organizes and attends site visits from sponsors and other relevant study meetings. 12) Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols. 13) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. 14) Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication. 15) Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions. 16) Understand the federal research regulations and identify the federal research organizationsâ™ role in regulating human research participation. 17) May prepare and maintain protocol submissions and revisions.
Unit-preferred Competencies 1) Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines. 2) Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others. 3) Ability to communicate with tact and diplomacy. 4) Strong organizational skills. 5) Strong communication skills (verbal and written). 6) Ability to handle sensitive matters with tact and discretion. 7) Excellent interpersonal skills. 8) Strong data management skills and attention to detail. 9) Ability to participate in protocol review and clinical trials evaluations. 10) Knowledge of medical terminology / environment. 11) Ability to handle competing demands with diplomacy and enthusiasm. 12) Excellent time management and ability to prioritize work assignments. 13) Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat. 14) Familiarity with Good Clinical Practices (GCP). 15) Ability to read and understand clinical trials protocols. 16) Understanding of the IRB submission and review process and when and how to apply for IRB review. 17) Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation. 18) Ability to absorb large amounts of information quickly. 19) Adaptability to changing working situations and work assignments.
1) One year of research experience or relevant experience
2) Knowledge of medical terminology/environment
2) Cover letter
Note: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
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