Job Title: Clinical Research Coordinator - RN/LPN
Division/Department: Research
Reporting Relationship: Director of Clinical Research
Location of Job: Germantown office - 1261 Goss Avenue, Louisville, KY 40217
Work Schedule: Flexible
Objectives:
Ensure the safety and well-being of all study subjects throughout the trial.
Support and adhere to Good Clinical Practices (GCP's), Federal Regulations and ethical standards as set forth in Family Allergy and Asthma SOP manual, the Federal Code of Regulations and as provided by Sponsors where appropriate.
Execute assigned coordination duties in a timely, accurate and efficient manner.
Ensure the proper and timely maintenance of study related documents, including study files, patient charts, and supporting documentation.
Promote personal and professional relationships by incorporating Family Allergy and Asthma core values of: Care, Advocacy, Service, Integrity, Accountability, and Fun in daily performance.
Duties and Responsibilities:
Assume primary responsibility for protocol initiation; from start to finish; to include, but not limited to:

1. Assists in evaluating new protocols for feasibility at the site:

•Reviewing the protocol, Investigator Brochure and Informed Consent Form.
•Assessing subject eligibility requirements to determine if the population exists and would be available in the practice.
•Assessing the ability to meet study timelines in light of other site commitments and overall feasibility.
•Assessing the resources necessary to perform the study, including people, physical space, and materials.
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1. Prepares the site for conducting the study, including:

•Setting up and organizing study files.
•Confirm that QA/accountability measures have been performed.
•Ensuring the people on the delegation of authority log have signed the log prior to implementation of the study and have completed protocol required training.
•Review or create study-specific source documents.
•Develops and implements recruitment plan, including advertising efforts.
•Collecting documents needed to initiate the study and sending them to the sponsor.
•Submits IRB documents.
•Attends investigator meetings.
•Actively seek assistance when clarification is needed from the sponsor.
•Attends site initiation meetings (either as primary coordinator or backup coordinator).
•Creates source documents.

1. Participates in the informed consent process which may include:

•Interacting with the sponsor and/or IRB on informed consent wording issues.
•Presenting the informed consent document to potential subjects, discussing the consent and the study with them, and answering any questions or concerns.
•Obtaining subjects' signatures on the informed consent forms.
•Ensuring all necessary signatures and dates are on the informed consent forms appropriately.
•Ensuring all amended consent forms are appropriately implemented and signed.

1. Manages study conduct throughout the trial which includes:

•Assures IRB approval is obtained prior to enrolling patients.
•Contacting and screening potential subjects.
•Recruiting subjects.
•Ensures adherence to study protocol.
•Scheduling subject and sponsor visits.
•Preparing for each subject visit to ensure all appropriate protocol specified procedures are completed.
•Maintains all materials, supplies, and equipment.
•Attempt to meet study enrollment goals or to exceed them if allowed.
•Promote subject retention.
•Assisting the investigator with study subject visits.
•Ensures investigator has reviewed and signed all subject and study related reports, eligibility and/or correspondence.
•Adverse event reporting includes lab abnormalities and their follow up reporting.
•Notifies Sponsor, IRB and Principal Investigator of any and all serious adverse events and for completing required documentation concerning these events.
•Dispenses study medication/device and maintains appropriate documentation of instructions to the subject(s), accountability, and destruction.
•Collecting and recording all necessary data in the appropriate source document and case report form in a timely manner as indicated per protocol.
•Works with sponsor monitors (CRAs) during monitoring visits.
•Prepares for monitoring visits by completing all CRF's, gathers charts and assures adequate workspace available.
•Makes corrections to source and case report forms, if appropriate.
•Resolves data queries.
•Ensures study documents are complete, current and filed correctly.
•Ensures IMP accountability is performed correctly for each subject and overall.
•Manages laboratory procedures (drawing samples, processing, handling of dry ice, packaging, and shipping).
•Reordering study supplies as necessary.
•Managing compensation to study subjects with documentation.
•Works with other members of the research team to ensure backup and coverage and to promote recruitment efforts.
•Organizes the technical aspects of implementation of study related testing, (PFT, skin testing, ECG's, etc.) and ensures functionality and maintenance of equipment.
•Maintains communication with Sponsor for study timelines/updates.
•Completing study closeout activities at the end of the study.

1. Other duties of a CRC include:

•Actively recruits assigned protocols, as well as other protocols.
•Assists other CRCs with their subject and monitoring visits.
•Ensures all study documentation is accounted for, organized, and packed to prepare for long term storage.
•Informs Director of Clinical Research of all monitoring visits, FDA audits or Sponsor audits as soon as information is available.
•Responsible for attending all staff meetings, in-services, and continuing education programs as directed by Director of Clinical Research or Investigator.
•Tasks delegated will be within one's training/certification/practice/license guidelines.
•Willing to work towards National Certification per ACRP guidelines.
•If applicable, maintain CCRC accreditation.
•Maintain and follow HIPAA policies and procedures.
•Other relevant duties as assigned by Director.
Requirements
EDUCATION, PRIOR WORK EXPERIENCE, SPECIAL SKILL AND KNOWLEDGE REQUIREMENTS:
Licensed RN/ LPN or 2 years', minimum medical practice/office experience. Research experience preferred. Extensive knowledge of medical terminology. Previous computer experience. CPR certified. ACRP Certified preferred.
PHYSICAL/ENVIRONMENTAL WORKING CONDITIONS:
Medical/Research office.
EQUIPMENT/MACHINERY USED:
Computer, Pulmonary Function testing, ECG, Centrifuge, Fax, Copier, Digital Stadiometer, Peak Flow Meter, Manometer, Digital Thermometer, Nebulizer.