Biospecimen Coordinator

CCR CTCA Clinical Research, Inc.; Goodyear (AZ); On-site; USD 60,000 - 95,000; Full time

Job summary

City of Hope is seeking a Biospecimen Coordinator to support clinical trials with rigorous data management and specimen handling. You will help establish data standards, assist with study start-up, protocol review, CRF and database reviews, and define dataset specifications.

You will develop data correction processes, resolve discrepancies, perform data validation with source documents, and support study closeout with regulatory submissions; enter data in CTMS and generate enrollment reports;

Qualifications

• Bachelor’s degree in a life science, computer science or related field or equivalent.
• Minimum of 1 year in Clinical Data Management, industry, or research experience.
• Knowledge of medical/oncology terminology and data handling practices.

Responsibilities

• Build and maintain data standards for clinical trials and biospecimens.
• Assist with study start-up: protocol review, CRFs, and database review.
• Define dataset specifications, data transfer specs, and handling plans.
• Develop data correction processes, discrepancy resolution, and validation with source documents.
• Support studies from preparation to closeout, including regulatory submissions.
• Ensure FDA/ICH guidelines compliance and CTMS data entry with enrollment reports.
• Process and ship biospecimen samples per protocol and IATA requirements.

Skills

Clinical Data Mgmt

Oncology terminology

MS Access

Excel

EDC systems

Education

Bachelor’s degree (life science, computer science or related)

Tools

Inform

TrialManager

Medidata

RedCap

Job description

Biospecimen Coordinator

About City of Hope, City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life‑threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute‑designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas.

The Rep, Clinical Data Research may consent patients on non‑therapeutic studies. Responsibilities will include building and maintaining data standards for all clinical trials. Assist with study start-up including protocol review, case report form and database review; dataset specifications, data transfer specifications, and review of data management and handling plans. Develop and implement the data correction process, discrepancy resolution, data control activities, and data validation with source documents. Support clinical trial studies from preparation through closeout including regulatory submissions by standardizing data management. Ensure source documentation and management of clinical study data is in accordance with FDA regulations and ICH/GCP guidelines Attend all SIVs and Monitor visits. Enter data in the CTMS and provide weekly/monthly enrollment reports. Process and ship research patient laboratory samples per protocol and IATA requirements.

All employees within this job classification may have exposure to blood‑borne pathogens, other potentially infectious materials, and/or hazardous chemicals/waste.

The successful candidate

***Shift: M-F typical business hours*** The Rep, Clinical Data Research/Biospecimen Coordinator may consent patients on non‑therapeutic studies. Responsibilities will include building and maintaining data standards for all clinical trials. Assist with study start-up including protocol review, case report form and database review; dataset specifications, data transfer specifications, and review of data management and handling plans. Develop and implement the data correction process, discrepancy resolution, data control activities, and data validation with source documents. Support clinical trial studies from preparation through closeout including regulatory submissions by standardizing data management. Ensure source documentation and management of clinical study data is in accordance with FDA regulations and ICH/GCP guidelines Attend all SIVs and Monitor visits. Enter data in the CTMS and provide weekly/monthly enrollment reports. Process and ship research patient laboratory samples per protocol and IATA requirements.

Position Qualifications

• Bachelor’s degree (in a life science, computer science or related discipline) or equivalent work experience.
• Minimum of 1-year Clinical Data Management, Industry, or Research‑related experience.
• Thorough knowledge of medical/oncology terminology and experience using Microsoft Access and Excel or EDC systems to include Inform, TrialManager, Medidata and RedCap.

City of Hope is an equal opportunity employer. City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.

Each of us at City of Hope believes in and is dedicated to turning hope into reality. Every researcher, nurse, doctor, administrative professional or IT specialist brings his or her unique creativity and talent to the fight against cancer, diabetes and other life‑threatening illnesses. Whether your interest is in the clinical, business, science or support service area, at City of Hope you will collaborate with the best and brightest colleagues, be challenged by engaging tasks and impact the lives of many people.