The mission of the Coordination Services and Education (CSE) unit in the CTSI's Office of Clinical Research (OCR) is to provide a sales and service solution to investigators who need assistance with clinical research study start up, on-study visit and patient management, regulatory maintenance, data entry services and clinical research training and education through three dedicated teams: Study Activation Team, Clinical Research Coordinator Team and the Education and Training Team. The incumbent will support pre-award study startup activities and post award study conduct activities including protocol development and revisions, case report form development and revisions, FDA submissions and correspondence (when applicable),
Quality Improvement and Quality Assurance (QI-QA) and other study startup and on study regulatory and administrative tasks necessary for study activation and compliant study conduct. The incumbent will The incumbent will collaborate with Investigators support multiple clinical research projects ensuring adherence to federal/local/institutional regulatory requirements, good clinical practice, data quality, protocol compliance, protection of human subjects, and overall quality assurance and quality management.
Coordinate and participate in pre-enrollment research activities for clinical studies conducted by department or division faculty.
Coordinate pre-enrollment monitoring visits, including Site Qualification Visits, Site Initiation Visits.
Assist in completion of study feasibility assessments with supervisor and study Investigator(s)
Assist in protocol development of investigator initiated studies, in collaboration with FDA Affairs team
Oversee and manage compliance with all Federal, State, and local laws and regulations, including but not limited to: FDA CFRs, FDA Good Clinical Practice (GCP), FDA Good Laboratory Practice (GLP), other Federal Agencies' requirements (i.e., NIH guidelines), HIPAA regulations and applicable laws and regulations governing clinical research endeavors.
Bachelor's Degree in science or related field
Nursing degree (such as RN or BSN) with clinical Nursing experience that includes procedural care
5+ years' experience in a clinical setting
Current RN license
Clinical research experience as a Study Coordinator in research involving human subjects, particularly the regulatory aspects of clinical research.
Working knowledge of FDA Good Clinical Practice and Good Laboratory Practice.
Ability to work efficiently and complete tasks with a high degree of accuracy.
Ability to effectively organize and manage multiple projects simultaneously.
Strong analytical skills sufficient to work and problem solve with minimal supervision.
Ability to work flexible hours to accommodate research deadlines.
Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines.
Strong interpersonal communication skills to effectively and diplomatically interact with others.
Strong written communication skills to compose correspondence.
Strong computer skills and experience working with Microsoft Office Applications, and able to perform the following tasks effectively: word processing, use and development of spreadsheets, e-mail and data entry (MAC, PC, MS WORD, MS EXCEL, MS OUTLOOK).
Ability to handle confidential material with discretion in accordance with Federal, State, and local laws and regulations, and consistent with Institutional policies.
Working knowledge of Institutional Review Board & Contracts and Grants policies and procedures.
Demonstrated experience in writing research correspondence to IRB and study sponsors.
Skill in coordinating diverse, complex tasks and information transfer among administrators, staff, committee members, and investigators.
Ability to effectively respond and resolve sponsor queries, both written and verbal.
Working knowledge of informed consent forms to ensure compliance with applicable laws and Institutional policies.
Ability to track regulatory documents that include laboratory certification, CV's, IRB compliance and correspondence letters, medical licenses, FDA Form 1572, Delegation of Authority Forms, Serious Adverse Event submissions, MedWatch/IND submissions, etc.
Ability to travel, as required and assigned, to attend meetings and conferences.
ACRP, SOCRA, or similar research related certification. Required within 6 months of starting position.