Biospecimen Coordinator

City of Hope; Goodyear (AZ); On-site; USD 60,000 - 80,000; Full time

Job summary

City of Hope is seeking a Biospecimen Coordinator to support clinical trial data management, specimen handling and data standardization across studies.

Responsibilities include protocol review, CRF and database review, data validation, and regulatory submissions, with emphasis on FDA/ICH-GCP guidelines. Shift: M-F business hours, exposure to laboratory materials may occur.

Qualifications

• Bachelor’s degree in a life science, computer science or related discipline.
• 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.

Responsibilities

• Build and maintain 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.
• Enter data in the CTMS and provide weekly/monthly enrollment reports.
• Process and ship research patient laboratory samples per protocol and IATA requirements.

Skills

Clinical Data Management

Data standards

Regulatory compliance

CTMS data entry

IATA handling

Education

Bachelor’s degree in life science or related discipline

Tools

Microsoft Access

Excel

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

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.