RN Clinical Research Coordinator

LCMC Health•New Orleans, LA

42d

About The Position

The RN Clinical Research Coordinator is a specialized research professional working with and under the direction of clinical staff. Implements, executes, manages and coordinates the daily clinical trial activities in accordance with Good Clinical Practice Guidelines. Plays a critical role in the conduct of clinical studies. Functions as a project manager for clinical trials in assigned area(s) of responsibility. Supports and provides guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Requirements

2 years of clinical research experience.
Bachelor's Degree Nursing
Valid license or temporary permit to practice professional nursing in Louisiana. American Heart Association, Basic Life Support Health Care Provider.
Established interpersonal skills combined with the ability to be highly motivated and work independently.
Well organized and able to maintain accurate and complete research records.
Excellent phlebotomy skills.
Extreme attention to detail.
Ability to be a team player.
Ability to work in a fast-paced environment.

Responsibilities

Initiation of Clinical Trials and Research Studies:
Coordinates and facilitates site qualification visits. Assists in evaluation of all potential clinical research studies.
Maintains communication with sponsor representatives, including acquisition of case report forms, device and/or drug stock, study tools and related documents.
Identifies study specific tests and procedure protocols, contacts appropriate departments and facilitates required training, certification and validation.
Assesses protocol requirements for patient care and provides necessary instruction.
Assembles updates and maintains study packets, including consents, inclusion/exclusion check list, sponsor contact information and other related information.
Provides colleagues with study information for protocol screening binders. Prepares and distributes study specific flyers for ancillary staff and departments.
Coordinates in-service/training for physicians, departments and appropriate staff with supervision.
Enrollment of research subjects:
Screens for patients in appropriate departments and participating physician offices.
Completes and submits screening forms.
Maintains contact with principal investigators and sub-investigators to promote study and encourage patient enrollment.
Promotes protocol compliance by being in clinic/physician's office/lab/OR when subject is seen or leaves guidelines for investigator or sub-investigator to follow.
Orders all protocol required labs, tests, procedures and medications.
Manages studies prospectively to prevent protocol deviations.
Enters patient enrollments in the CTMS. Maintains screening, enrollment logs and provides to sponsor within established timeframe.
Collects and organizes clinical trial data:
Ensures all study documentation is accurately maintained, utilizing sponsor source documents or develops source documents as necessary.
Responds to data clarification requests adequately.
Maintains confidentiality of Protected Health Information (PHI) and keeps all records secure.
Requests charts and office notes from referring physicians and investigators to retrieve/capture data.
Manages study subject visits and follow-up:
Follows study patient both in-patient and out-patient throughout course of study.
Orders all protocol required follow-up labs, tests, procedures and medications accurately and according to area of responsibility SOPs.
Monitors for adverse events including daily review of study patient hospitalizations. Collaborates with attending physician and principal investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframe.
Manages assigned study budget and administration:
Assists in the preparation of the budget for study-related costs and associated services.
Record patient visits and services in the CTMS.
Invoice sponsor and tracks reimbursements.
Functions within the guidelines of HIPAA, JCAHO, OSHA, federal, state and other regulatory agencies including OHRP, GCP and FDA guidelines.
Acts as liaison between research department, physician practices, hospital and staff.
Ensures submission of all regulatory documents and correspondence.