Senior Central Services Coordinator

ALLIANCE CLINICAL LLC•Southlake, TX

9d•Remote

About The Position

The Senior Central Services Coordinator oversees the daily operations of multi-site clinical research programs on required protocols. The Senior Central Services Coordinator works virtually with the central services team, on-site clinical staff, and patients to ensure study protocols are met.

Requirements

Minimum of 4 years of experience working in Clinical Research, required.
Minimum of 4 years of experience leading clinical research teams.
Minimum of 2 years of experience in healthcare, required.
Minimum of 2 years of experience working with FDA regulations and Good Clinical Practice (GCP) guidelines.
Comprehensive knowledge of FDA, GCP and HIPAA as applied to clinical research.
Knowledge of safety hazards and procedures that establish a safe work environment.
Skilled in using computers and data collection software.
Excellent customer service skills with internal and external stakeholders.
A proven ability to multi-task in a rapidly changing environment.
Maintain GCP certification and other on-the-job certifications as required.

Nice To Haves

Associate’s degree in healthcare or related field, preferred.

Responsibilities

Lead the Central Services team in virtual clinical research coordination of study subjects and ensure high-quality adherence to study protocol.
Oversee the quality standards of the Central Services processes and protocols.
Train and oversee Central Services Coordinators and Central Service Coordinator Juniors (JRs).
Communicate the efficiency and productivity results of the team to management and actively source solutions for improvements.
Virtually communicate effectively and courteously with study patients via telehealth platform.
Demonstrate a caring and pleasant demeanor toward patients and their families.
Acknowledge study patients' needs and address them appropriately.
Collect patient medical histories and document relevant medical conditions.
Conduct study visits across all sites via a telehealth platform.
Ensure informed consent forms are properly obtained and documented by on-site staff.
Review and complete participant study visits in accordance with protocol requirements.
Ensure data quality.
Collect and evaluate medical records for compliance.
Conduct A/E (Adverse Event) and SAE (Serious Adverse Event) assessments.
Ensure accuracy of collected study data.
Review study eSource documents for compliance with study protocols.
Manage all required study documentation, training, and timelines on assigned study protocols.
Participate in CRO/Sponsor/Audit interactions.
Meet deadlines and goals as assigned.
Perform other duties as assigned.