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.