Clinical Research Coordinator II- Winship Cancer Institute

Emory•Atlanta, GA

10d

About The Position

About Winship Cancer Institute of Emory University Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia’s only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient’s needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope®. For more information, visit winshipcancer.emory.edu. Winship is seeking qualified candidates for the Clinical Research Coordinator II position. Position details are as follows: The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials. The Clinical Research Coordinator II (CRC II) Key responsibilities include direct handling or assisting with research activities associated with tissue and sample collection in the Glenn Family Breast Center. The goal of these projects is to build a large-scale repository of biospecimens with associated clinical and genomic data to support breast cancer research activities. The candidate will be responsible for overseeing, planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. These activities include but are not limited to the oversight of patient screening, eligibility determination, registration and other protocol and subject milestones. The position works within a multidisciplinary environment with colleagues both internally and externally in a cooperative manner exercising respectfulness and professionalism. The CRC II will have direct patient contact and is responsible for managing and performing the clinical and operational aspects of moderately to highly complex study protocols.

Requirements

High School Diploma or GED and five years of clinical research experience.
Or two years of college in a scientific, health related, or business administration program and three years clinical research experience.
Or a licensed as a practical nurse (LPN) and two years clinical research experience.
Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience.
Or a Master's degree, MD or PhD in a scientific, health related or business administration program.

Nice To Haves

Professionalism, good judgment, and ability to work with confidential material and protected health information.
Advanced interpersonal, oral, and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.
Self-directed with the ability to work, plan, research, and manage multiple studies with minimal supervision, on a flexible schedule, and with best practice expertise.
Advanced ability to manage multiple/diverse studies simultaneously.
Proven ability to multi-task and remain focused in a fast-paced environment.
Knowledge of regulatory processes for non-therapeutic research studies, Good Clinical Practice (GCP) guidelines, applicable federal regulations, and institutional practices, standards, policies, and procedures at the unit/functional level.
Strong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.).
Experience in patient recruitment and conducting the informed consent process.
Knowledge of clinical research management systems.
Demonstrated experience documenting in an Electronic Medical Record (EMR).
Oncology experience.
This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher.

Responsibilities

Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms.
Provides guidance to less experienced staff.
Interfaces with research participants, determines eligibility and consents study participants according to protocol.
Approves orders for supplies and equipment maintenance.
Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires.
Supervises collection of study specimens and processing.
Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed.
Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors.
Prepares regulatory submissions.
With appropriate credentialing and training may perform phlebotomy or diagnostics.
Performs related approved responsibilities as required.
Serves as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols involving tissue and sample collection.
Manages, implements, and evaluates all aspects of study conduct with tissue collection including study initiation, execution/maintenance, completion, and administration.
Ensures study protocols are adhered to, oversees the maintenance of accurate documentation, recruitment of study participants and regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional requirements.
Analyzes, documents and conveys study data.
Collaborates with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner.
Oversees the tracking and reporting of, protocol waivers, deviations, and violations.
Performs other duties as assigned.