Senior Clinical Trials Lead & Study Coordinator

Ochsner Health; Louisiana; On-site; USD 65,000 - 95,000; Full time

Job summary

Ochsner Health in Louisiana seeks an experienced clinical trials professional to evaluate, initiate, and maintain activities related to the conduct of clinical trials. You will coordinate patient care requirements, serve as a liaison for patients and the Principal Investigator, and mentor junior staff.

Required are a high school diploma, 5 years of clinical research experience, and 4 years with ACRP or SOCRA certification.

Qualifications

• Knowledge of medical and clinical research terminology.
• Expert understanding of ICH guidelines for ethical conduct of research.
• Familiarity with lean management principles.
• Ability to follow and provide critical feedback on the investigational plan.
• Ability to develop study related budgets, contracts, and patient consent documents.
• Ability to mentor junior staff members on the requirements and regulations associated with the conduct of clinical trials and other related research activity.
• Expertise in using Epic (Super-Users).
• Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
• Strong interpersonal and leadership skills and ability to coach others, as well as effectively work independently.
• Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and develop new techniques.
• Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts.

Responsibilities

• Evaluates competing strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings and coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials, serving as a liaison for both patient and Principal Investigator (PI).
• Serves as primary point of contact for patient to report and triage adverse events and serves as a mentor to staff on obtaining informed consent.
• Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
• Performs clinical laboratory activities as required per protocol and maintains study supplies and equipment.
• Maintains close communication with study sponsor representatives including but not limited to site initiation, maintenance, and close out of studies.
• Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
• Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution and transcribes information across various internal and external electronic data systems.
• Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
• Provides mentorship, professional development, and support to less senior team members and interns; assesses quality assurance of study visits and data; periodically reviews and provides constructive feedback on standard operating procedures; and coordinates special projects related to workflow optimization.
• Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style.
• Performs other related duties as assigned.

Skills

Clinical research knowledge

Communication skills

Leadership

Time management

Travel flexibility

Education

High school diploma or equivalent

Tools

Epic (Super-Users)

SAS/EDC systems

Job description

Ochsner Health in Louisiana seeks an experienced clinical trials professional to evaluate, initiate, and maintain activities related to the conduct of clinical trials. You will coordinate patient care requirements, serve as a liaison for patients and the Principal Investigator, and mentor junior staff.

Required are a high school diploma, 5 years of clinical research experience, and 4 years with ACRP or SOCRA certification.