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Clinical Research Coordinator II

4 months ago

Dallas, United States Bauer's Intelligent Transportation Full time

Clinical Research Coordinator II

Job Details

Job Location

Presbyterian Hospital of Dallas/DCPM - Dallas, TX

Position Type

Full Time

Job Shift

Day

Job Category

Health Care

Description

Clinical Research Coordinator (CRC) II comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal and hospital regulations. Some responsibilities of the Clinical Research Coordinator (CRC) II depending on need include:

+ Facilitate and coordinate the daily cancer clinical trial activities

+ Coordinate clinical trials per Good Clinical Practice and CFR guidelines

+ Work directly with on-site research staff of Investigators, Nurses, Medical Assistants.

+ Accurate and timely trial data collection and reporting

+ Submit regulatory documents to IRB and Sponsor

+ Attend investigator meeting(s)

+ Obtain physician and staff signatures

+ Recruit subjects/patients

+ Screen, track and schedule trial pts

+ Coordinate the Informed Consent Process, ensuring all patients are properly consented prior to initiating clinical trial procedures

+ Teach subjects/patients about protocol expectations for trial visits

+ Perform study/protocol procedures in a detailed, accurate manner

+ Maintain study files completely and accurately

+ Report all adverse events and SAEs within required timelines

+ Collect laboratory specimens, process/ship lab work

+ Maintain communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel.

+ Complete case report forms (CRF) and electronic data capture (EDC) for PI review and approval

+ Respond to all data queries and sponsor requests in a timely manner

+ Coordinate site study monitor and sponsor visits

+ Maintain study-specific supplies

+ Prepare for study closure and archiving

+ Maintain appropriate training required to carry out protocol-driven activities as delegated by the PI

+ Other duties within the scope of a Clinical Research Coordinator

Qualifications

Job Qualifications:

+ 3-5 years of equivalent experience in medical clinic, research coordination required

+ CCRP, ACRP certification preferred but not required

+ Prior experience with Urology and Oncology clinical trials preferred

+ Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed.

+ Some EMR (electronic medical records) experience required

+ Some Electronic Data Capture (Rave, Oracle, Inform, etc.) experience required

Knowledge, Skills & Abilities:

+ Excellent organization and communications skills required.

+ Strong interpersonal skills ability to effectively interact with all levels of staff and external contacts.

+ Must be detail oriented and have the ability to follow-through.

+ Ability to effectively manage time and prioritize workload.

+ Must practice discretion and always adhere to site confidentiality guidelines.

+ Knowledge of medical terminology (Oncology and Urology preferred).

+ Knowledge of good clinical practice, FDA, OHRP, HIPAA policies.

+ Proficiency with the Microsoft Office Suite, Google Docs, SharePoint.