Clinical Research Coordinator II – Heart Valve Research

Clinical Research Coordinator II – Heart Valve Research

Requirements

• Clinical Research (Novice): Can research problems that span several areas of the department. Develops and writes basic trial protocols. Knows what information is available in the company. Designs data collection forms. Has developed networking skills which assist in researching issues.
• Study Design & Conduct (Novice): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
• Project Coordination (Novice): Reviews specific project related documents for completeness and accuracy and ensures project status reports are received, when due, from project managers for all approved projects. Provides administrative and logistics support for various project meetings, training, workshops and facilitated sessions. Coordinates and tracks all work requests to ensure on time project delivery. Keeps project plans updated and ensures key milestones and dependencies are understood. Responsible for record keeping for project meetings such as issues logs, gap analysis sheets, meeting minutes, making copies, team event planning and execution, team travel, on-boarding activities for contractors or consultants, set up and maintenance of project repositories.
• Communication (Novice): Clearly, effectively and respectfully communicates to employees or customers.

Responsibilities

• Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations.
• Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures.
• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required).
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation. Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation.
• Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures.
• Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation.
• With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies.
• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants.
• Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial.
• Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel.

Preferred Qualifications

No preferred qualifications provided.