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.