Associate clinical resesarch coordinator

Location
Duarte, California
Salary
Competitive
Posted
September 20 2020
Ref
10007916rxv_113_1
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Healthcare/Hospital
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary
The Clinical Trial Office (CTO) assists COH investigators with the management of research studies involving human subjects. , Senior Manager, Clinical Research Coordinators, and other senior leaders in the CTO and Clinical Research Operations, with input from the Disease/Modality Team Leaders and investigators, the staff of the CTO coordinate activities to support multiple research studies of all phases.
Under the direction of the Manager of Associate Clinical Research Coordinator (MACRC), the Associate Clinical Research Coordinators (ACRC) will maintain data integrity of assigned research studies. They are responsible for abstracting data, completing case report forms and answering queries. They schedule sponsor monitoring visits, meet with the monitors and maintain data in an audit ready state, meeting the requirements of the contract. A CRCs are also responsible for ensuring laboratory kits and any other necessary patient study specific equipment, is available and prepared in advance of patient visits. They are to ensure compliance to the research protocol, timely coordination of biospecimen collection, transporting and shipping of biospecimens obtained from subjects enrolled in complex research protocols. They must oversee the shipping and management of biospecimens for their assigned studies. They will collaborate with the Biospecimen Coordinator to ensure collection and shipment records of biospecimens are properly completed and maintained. Additionally, it is their responsibility to ensure patient data, for assigned studies, are up-to-date in the clinical research management system (CRMS).

Key Responsibilities include:
  • Works under the supervision of the Manager, Associate Clinical Research Coordinators (MACRC) with direction from Study Investigators and the Senior Manager, Clinical Research Coordinators.
  • Works in conjunction with a mentor to develop the skills to assume more responsibility and workload.
  • Performs protocol specific duties required per the research protocol, including:
  • Abstracts data from the medical record and completes paper and electronic case report forms,
  • Maintains all necessary source documents;
  • Obtains data, specimens and images from outside facilities as needed;
  • Responds to all requests for data clarifications;
  • Knowledgeable of sponsor requirements for timeliness of data and response to queries;
  • Ensures data collection is available per contract obligations at the time of monitoring visits;
  • Fulfills sponsor requirements related to reportable information, including: adverse events, unanticipated problems, other information required by the sponsor protocol.
  • Participates in audits and monitor visits for assigned studies, and as requested.
The ACRC ensures adherence to protocol for specimen collection as well as sponsor specific equipment procedures:
  • Ensures all study related biospecimen collections are prepare, collected, and shipped according to the protocol.
  • Participates, as needed, in the preparation and/or delivery of laboratory kits or study specific equipment for patient visits.
  • Guarantees the Biospecimen Coordinators complete and maintain patient-specific biospecimen documentation according to policy and regulations.
  • Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
  • Ensures application and adherence of Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations, ICH guidelines, and institutional policies in relation to clinical trials.
  • Ensure protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.
  • Enter data into the clinical research management system (CRMS) for study patient and ensure it is accurate and up-to-date.


Qualifications
Basic education, experience and skills required for consideration:
  • Bachelor's Degree; or AD/GED with 2 years research or similar experience.
  • At least one year of experience related to the management and conduct of oncology clinical trials in an academic setting, or six months experience as a Project Coordinator or Biospecimen Coordinator in the CTO. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.


Required Certification/Licensure:
  • Good Clinical Practice (GCP) and Health Information Portability and Accountability ACT (HIPAA)-to be provided by COH if not already completed.
Preferred education experience and skills:
  • Medical terminology

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

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