Jr. Clinical Research Coord

Job Description

Job Description

Overview

As a Junior Clinical Research Coordinator, you are responsible for assisting with the management and coordination of all aspects of conducting clinical trials within s RII, surgery centers, both clinically and administrative / regulatory.

Responsibilities

• Acts as a representative of clinical research and as liaison between investigators, other study staff, primary care providers, IRB and sponsor.
• Screens, consents, enrolls and follows study subjects ensuring protocol compliance and close monitoring while subjects are on study utilizing Research Nurses’ oversight for help with clinical decision making.
• Responsible for all data and source documentation, and adverse experience reporting
• Responsible for following departmental policies
• Responsible and for assuring proper billing for research subjects. Assures that charges for tests and treatments are appropriately communicated and processed.
• Assists as needed in preparing study for submission to IRB and ensures all regulatory documents are completed.
• Attends study-related meetings as appropriate.
• Travels between RCA research offices as needed for patient and business needs.
• Develops screening / enrollment / follow up mechanisms.
• Ensure adherence to protocol requirements.
• Schedules and performs patient procedures, assessments, evaluations and testing as required by the protocol, including but not limited to blood sample collection, processing and shipping, ECG, vital signs, etc., as applicable.
• Organizational maintenance of all aspects of the trial, including but not limited to timeliness in completing CRFs, reporting adverse events, managing caseload and study files.
• Responsible for quality data entry into sponsor’s database (electronic data capture systems or paper CRFs) and query resolution.
• Ensures proper study drug administration, compliance and accountability, including receipt and , storage and dispensing.
• Ensures patient safety and ensures coordination of patient care as needed.
• Assists with maintenance of regulatory documents, IRB reporting and submissions of amendments, renewals, etc.
• Assists with study initiation visits, monitoring visits, closeout visits and audit visit, ensuring all study documentation and study issues are addressed.
• Communicates regularly with the Manager of Clinical Research at RII and Principal Investigators about study related issues.
• Ensures compliance with department standards and all federal regulations and international guidelines of good clinical practice.
• Maintain job related certifications (IATA, Human subjects, subjects’ protection training, GCP, and protocol specific required training).
• Active in acquiring professional growth by obtaining CRC certification when eligible and joining a professional association such as SOCRA or ACRP.
• Performs other duties and responsibilities as required.
• Promotes a positive work environment and works to be an integral member of the team
• Encourage a team-oriented environment supporting the AVP Mission, Vision and Core Values.
• Participate in on-going training and continuing education.
• Show respect and deal appropriately with co-workers, patients, and visitors.
• Perform any and all duties assigned.

Qualifications

Certificates, Licenses, Registrations :