Clinical Research Coordinator II

Principal Duties and Responsibilities:

1. Recruitment/Enrollment- In conjunction with Clinical Research RN and various physician investigators in the Division of Transplant, develops and implements study recruitment strategies and procedures:

• Perform Institutional Review Board (IRB) submission process by preparing protocol applications, amendments, safety reports, adverse event reports and other documents

• Recruit and enroll eligible study participants from the inpatient hospital wards

• Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion

• Perform all patient related interviews in both the inpatient and outpatient settings

• Provide teaching and monitoring for research participant diaries

• Capture clinical information from record review and patient interview into study database

• Perform bio-specimen processing, as indicated

• Manage and maintain regulatory documents for audit by FDA, as needed

• Act as primary study resource for laboratory staff, patients and families

• Coordinate subject care by scheduling and arranging follow-up visits, conducting follow-up telephone calls, and communicating concerns with the study investigator

• Conduct regular review of study progress and follow-up

• Performs administrative support duties as required

• Attend weekly coordinator meetings, and prepare weekly reports of work performed

2. Regulatory Compliance- With supervision from the PI and/or Research Team, develops and maintains protocol specific documents, IRB amendments and reviews, and regulatory report submissions. Duties include:

• Verifies accuracy and updates study forms;

• Assists with study regulatory submissions, including preparing and submitting regulatory documents to study data repositories

• Maintains regulatory binders for trials in the Division of Transplant

• Contributes to protocol recommendations and communicates these with Clinical Research Manager, RN;

• Prepares protocols for review by the required hospital subcommittees: Pharmacy and/or IRB;

• Drafts amendments to protocols, based on requests and suggestions by the P.I., and submits these for IRB approval.

• Prepares annual renewal for the IRB Approval.

3. Data Management- Obtains and organizes patient data from medical records, physicians, etc., following HIPAA guidelines:

• Study data entry;

• Uses software programs to generate graphs and reports;

• Maintains research data, patient and study files

• Maintains study codes;

• Assists with formal audits of data

• Performs data analysis and QA/QC data checks

• Organizes and interprets data

• Monitors and evaluates lab and procedure data

• Administers/scores/evaluates study questionnaires

4. General Office & Laboratory Support:

• Oversees bio-tissue collection and sample processing, per study protocol

• Ships and stores specimens, as required by protocol.

5. Assumes additional administrative and clinical research tasks, as needed.

Skills/Abilities/Competencies Required:

• Extraordinary attention to detail, ability to work carefully and efficiently with limited supervision once appropriate training has been provided;

• High level of proficiency with Microsoft Excel, Word, PowerPoint and computer data entry skills required;

• Experience with medical chart reviews and electronic medical records (EPIC). Knowledge of database management strongly preferred;

• Ability to interpret acceptability of data results;

• Analytical skills and the ability to resolve technical problems.

• Good judgment and problem-solving skills, ability to juggle multiple tasks, people and schedules

• Ability to demonstrate professionalism, compassion and respect for study participants' rights and needs

• Excellent oral and written communication skills in English

• Ability to work both independently and as part of a busy, multidisciplinary team, interacting with diverse individuals at multiple levels within the research and clinical group