Summary

Job Description

POSITION SUMMARY: Plans, initiates, coordinates, implements, and oversees clinical trials within the LGHealth Research Institute under the direction of the clinical Principal Investigator (PI) who is responsible for the overall conduct and management of the clinical trial. Coordinates the daily clinical trial activities, and plays the critical lead role in the conduct of clinical studies in accordance with local, state, and federal regulations.  Must display dedication, enthusiasm, commitment, confidentiality, and flexibility with cross coverage of sites and with on-call hours when required.

HOURS: Monday-Friday dayshift hours. No weekends/evenings, or holidays.

ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:

• Plans and coordinates assigned research studies, serves as principle liaison for the project, interfaces with research subjects and collects research data, oversees administrative support, develops appropriate tools needed to conduct the research, and maintains record keeping systems and procedures.
• Ensures all research activities occur in compliance with guidelines for human subject protection research.  Ensures all key personnel engaged in the research study have met training requirements.  Serves as a resource to other research staff members regarding assigned clinical protocols.
• Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies.  Ensures billing of study procedures to the appropriate funding source.
• Provides regulatory oversight for the conduct of assigned clinical trials.  Prepares and oversees LG Hospital IRB submissions and continuing reviews, maintains regulatory and legal documents per IRB, FDA, DOH and other applicable regulatory agencies when required.
• Develops and implements recruitment strategies in accordance with sponsor requirements.  Oversees and conducts informed consent process under direction of Primary Investigator and maintains appropriate documentation according to GCP, FDA, and IRB guidelines.
• Maintains adequate inventory of study supplies. Oversees and maintains drug and medical device accountability according to regulatory guidelines for receipt, storage, dispensation, and return of investigational product according to SOPs policy on Investigational Drug/Device Accountability.
• Collaborates with other Research Coordinators, particularly in areas where clinical and non-clinical research areas interface.  Contributes to the mentoring of new research staff.  Functions as a resource for physicians, other health care providers, and ancillary support staff regarding care of the research participant as it relates to any given clinical research protocol; conducts staff in-services as appropriate.                         
• Coordinates and manages the patient assessments according to protocol standards at LGHealth locations, in a clinically safe and regulatory compliant manner.  Utilizes clinical knowledge and assessment skills necessary to evaluate, report, and record accurate medical information including response to therapy according to approved research protocol.
• Develops and maintains rapport with patients to promote adherence to treatment and data collection protocols.   Coordinates participant tests and procedures and maintains study timelines in data collection and completion of case report forms.
• Assures collected data for any approved research protocol is correct, sufficient, all inclusive, regulatory compliant and the integrity is intact.    Maintains study files in accordance with sponsor requirements and LGH SOP Policies, including consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Assures the source documentation of all research activities is completed and accessible for CRF completion, reporting purposes, and for site visits by Sponsors and other regulatory agencies.  Facilitates, conducts and oversees monitoring visits with Sponsors and other related agencies for the purpose of evaluating the accuracy and quality of the collected data.
• Maintains effective and ongoing communication with Sponsor, research participants and PI during the course of the study.

SECONDARY FUNCTIONS: The following duties are considered secondary to the primary duties listed above:

• Other duties as assigned.
• Performs rotating evening and weekend On Call coverage for active research trials if required.
• Travels to various LGHealth facilities as required to execute trials.   Travels to investigator and clinical research coordinator meetings.
• Attends and participates in research team meetings; educational research and clinically relevant workshops; and sessions provided by LGH to maintain skill sets, knowledge base, and continuing educational credits for both  licensure and research certification renewals.

JOB REQUIREMENTS

MINIMUM REQUIRED QUALIFICATIONS:

•  Bachelor’s degree in a health science or related field (eg, biology, public health, healthcare administration).
• Two (2) years’ experience in a research or clinical environment.
• Working knowledge of medical and research terminology.
• Comprehension of Federal Regulations for Human Subjects in research.
• Comprehension and certification in Good Clinical Practices (ICH/GCP) for human research.
• Computer Competency including proficiency in Microsoft Outlook, Word, Excel, electronic data capture and electronic health records (EHR) navigation.

PREFERRED QUALIFICATIONS:

• Research professional certification (CCRP) or willingness to pursue certification.

Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job.  It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards.  The percentages of time spent performing job duties are estimates, and should not be considered absolute.  The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole.  Incumbent must be able to perform all job functions safely.

Disclaimer