Clinical Trials Coordinator

Full Time
New Orleans, LA 70112
Posted
Job description
University Medical Center New Orleans is the academic medical center of LCMC Health and the ultimate expression of a nearly 300-year legacy of serving the people of New Orleans and South Louisiana. With our academic partners, including Louisiana State University and Tulane University Schools of Medicine, we are training the next generation of healthcare professionals and leading research to find tomorrow's cures and treatments. From expert primary care and the widest variety of specialty care to cutting edge emergency care and the region's only Level 1 Trauma Center, UMC offers the area the widest breadth of healthcare services.

Click here to view our state-of-the-art facility.

We are looking for medical professionals who are just as passionate as we are about providing the best medical care in the safest environment. We are an equal opportunity employer that values diversity in the workplace. Whether you're a seasoned healthcare professional or just starting out, a career at UMC places you at the center of a dynamic community of providers, learners and staff with a singular focus on patient-centric care. We offer a state-of-the-art facility with breakthrough technology, and professionals committed to helping our community become healthier.

Position Summary: The purpose of this position is to, in collaboration with UMCNO/LCMC research administrators, principal investigators and sub-investigators, ancillary research staff/RN’s, industry sponsor CRA’s and affiliated personnel, implement and conduct specific trial related activities under the direction of the Principal Investigator and within current ICH guidelines.

Job Specifications:

Education: Graduate of an accredited Bachelor degree program with emphasis in public health or biology. Master of Science degree preferred. CPR certification. Willingness to pursue research certification via an accredited program. IATA certification/CITI training are required within 30 days of hire.

Experience: Knowledge of Oncology clinical trials preferred. Prior experience working with/managing patients in inpatient or outpatient health care setting, preferred.

Skills: Proficiency with health care related software/data input systems. Ability to learn/adapt to new systems when introduced or presented. Proficiency with Microsoft Office/Excel.

Must exhibit exceptional interpersonal and communication skills.

Advanced time management and organizational skills are a must. Ability to adapt/be flexible with emphasis on multi-tasking.

Ability and willingness to travel to affiliate site location (West Jefferson Medical Center) on a weekly basis.

The Clinical Research Associate/Data Manager exhibits advanced competencies required to conduct industry sponsored clinical research:

  • Maintains a competent level of knowledge related to anatomy, disease process, medical terminology, tests and procedures, and treatment plans.
  • Exhibits proficiency with Microsoft Office/Excel
  • Exhibits a high level of organization, planning, and controlling of work flow as these activities relate to conducting clinical trials activities; must possess meticulous attention to detail and ordering of priorities.
  • Assists with and participates with facilitation of site feasibility and initiation visits: preparation of documents, review of protocols to include background, rationale and objectives, description of study drug/device, review of inclusion and exclusion criteria, review of schedule of events/visit specific requirements, tests, procedures, and concomitant medications.
  • Assembles, updates, and maintains screening and study binders for each study: inclusion/exclusion criteria, study schema, study calendar of events, treatment plans, sponsor and PI contact information, and any study specific information and amendments.
  • Assists with screening and identification of patients for clinical trials, maintains consistent communication with principal investigators and sub-investigators to promote studies and encourage patient enrollment
  • Independently performs informed consent process for Oncology clinical trials for UMC and West Jefferson Infusion Center
  • Maintains screening and enrollment logs prospectively and provides to sponsor as required.
  • Exhibits proficiency and performs collection, input and management of paper case report forms as well as electronic data base management systems; completes forms and responds to data clarification requests as needed.
  • Ensures all study documentation is accurately maintained, utilizes study specific source documents or develops source documents as necessary
  • Assists with collection, processing, and shipment of biospecimens; working knowledge of biospecimen batching/storage and records keeping.
  • Attends staff/research meetings and tumor board meetings, serving as resource and liaison between research department, physician groups, inpatient and outpatient ancillary staff, and CRA’s, study sponsors.
  • Follows study patients both inpatient and outpatient throughout the course of the study; Informs subjects of changes/amendments to protocols, is present for all required/unscheduled visits and communicates with other study team members regarding patient concerns/observations as these relate to conduct of clinical trial.
  • Maintains confidentiality of PHI and assists with obtaining information from outside sources such has referring physician offices or investigators.
  • Functions within the guidelines of HIPAA, JCAHO, OSHA, federal, state, and other regulatory agencies, including OHRP, GCP, and FDA guidelines.
  • Functions independently and proficiently as defined in the position essential functions with minimal supervision.
  • Articulates and demonstrates professional image in interaction with patients, investigators, sponsors, other professionals, and colleagues.

UMC is an equal opportunity employer and all qualified applicants will 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.



Location: LCMC Health · Clinical Research
Schedule: Full-time, Days, 8am-4:30pm

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