- 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.
- 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.
- 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.
- 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.
- 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.
- Does this position formally supervise employees? No
- Deliver healthcare with heart.
- Give people a reason to smile.
- Put a little love in your work.
- Be honest and real, but with compassion.
- Bring some lagniappe into everything you do.
- Forget one-size-fits-all, think one-of-a-kind care.
- See opportunities, not problems - it's all about perspective.
- Cheerlead ideas, differences, and each other.
- Love what makes you, you - because we do
- To get started, take your time to fully and accurately complete the application for employment. Incomplete applications get bogged down and are often eliminated due to missing information.
- To ensure quality care and service, we may use information on your application to verify your previous employment and background.
- To keep our career applications up-to-date, applications are inactive after 6 months and, therefore, require a new application for employment to be completed.
- To expedite the hiring process, proof of citizenship or immigration status will be required to verify your lawful right to work in the United States.
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RN Clinical Research Coordinator/ Full Time - New Orleans, United States - LCMC Health
Description
Your job is more than a job.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.
GENERAL DUTIES
Initiation of Clinical Trials and
Research Studies:
Enrollment of research subjects:
Collects and organizes clinical trial data:
Manages study subject visits and follow-up:
Manages assigned study budget and administration:
EXPERIENCE QUALIFICATIONS
2 years of clinical research experience.
EDUCATION QUALIFICATIONS
Bachelor's Degree Nursing
LICENSES AND CERTIFICATIONS
Valid license or temporary permit to practice professional nursing in Louisiana. American Heart Association, Basic Life Support Health Care Provider.
SKILLS AND ABILITIES
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.
REPORTING RELATIONSHIPS
WORK SHIFT:
Days (United States of America)
LCMC Health is a community.
Our people make health happen.
While our NOLA roots run deep, our branches are the vessels that carry our mission of bringing the best possible care to every person and parish in Louisiana and beyond and put a little more heart and soul into healthcare along the way.
Celebrating authenticity, originality, equity, inclusion and a little "come on in" attitude is the foundation of LCMC Health's culture of everyday extraordinaryTouro
Touro, at the forefront of medical excellence within LCMC Health's incredible community of care, has been regionally recognized for 165 years as one of New Orleans' most enduring healthcare monuments.
Your extras
LCMC Health is an equal opportunity employer.
All qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
The above job summary is intended to describe the general nature and level of the work being performed by people assigned to this work.
Simple things make the difference.
