• Jobs in Healthcare
  • Duarte, CA
  • Posted 5 months ago

Website City of Hope

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 5000 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 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

Description:

The Clinical Trial Office (CTO) assists COH investigators with the management of research studies involving human subjects. Under the direction of the Senior Director, Clinical Trial Office and the CTO leadership team with input from the Disease Team Chairs and the Study Investigators, the staff of the CTO coordinates activities to support multiple research studies of all phases. Research Coordinators (RC) are focused on one of three clinical research tracks, with cross coverage provided by other members within the research team.

The Regulatory Track RC is responsible for submission of studies through the various regulatory committees, including scientific review and IRB review. Regulatory Track RC serves as the liaison with the various IRBs who review COH research including City of Hope, Western IRB, and Central IRB of the National Cancer Institute, Schulman IRB, and any other IRB that may enter into an agreement with COH. They work with investigators and sponsor to address oversight committee conditions and requests for information. COH uses Integrated Research Information System (iRIS) as its electronic protocol submission system. This track is responsible for ensuring regulatory compliance to the research protocol, adhering to all appropriate regulations.

The Data Track RC is responsible for maintaining data integrity of assigned research studies. They are responsible for abstracting data, completing case report forms, and answering queries. They schedule and meet with sponsor monitor visits and maintain data in an audit ready state, meeting the requirements of the contract. Together with the Clinical Research Track RCs, they are responsible for ensuring compliance to the research protocol and all appropriate regulations.

The Clinical Research Track RC is responsible for ensuring compliance to the research protocol and all appropriate regulations. They attend clinic, when required, and assist the Clinical Research Nurses with study management and ensure patient satisfaction and understanding with protocol requirements. They assist with recruitment activities, administer questionnaires, answer questions about future appointments, register, and randomize patients to study. It is their responsibility to create and maintain the research record, help with insurance authorization, and maintenance of the financial calendars.

Key Responsibilities include:

Basic Requirements for Associate Research Coordinators

  • Knowledgeable in Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations and ICH guidelines in relation to clinical trials. If not already familiar, become familiar with institution Policy and Procedures with particular emphasis in conducting multiple clinical research trials.

  • Monitor and coordinate multiple research projects in order to assess the need for and to implement strategies to ensure the conduct of quality research, the achievement of expected time lines and deliverables, and the efficient use of human and practical resources.

  • Troubleshoot problems at all stages of project development and implementation and assist with modifying protocol or project procedures to address challenges.

  • Ensure protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.

  • Work as a member of the clinical research team with positive and timely written and verbal communication, including sharing information up, down and laterally.

  • Shows initiative to identify and implement ways to improve job and surroundings

  • Works in conjunction with a mentor to develop necessary skills to complete assignments and tasks.

  • Seeks supervision appropriately.

  • Plans work in a manner that allows timely completion of all assignments and tasks.

  • Demonstrates accuracy in all details.

  • Develop and maintain knowledge of institutional protocol submission procedures and requirements.
  • Maintain a processing and tracking system for all protocol related paperwork.
  • Manages low complexity trials after completion of orientation.

Basic Requirements for Associate Research Coordinators

  • Knowledgeable in Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations and ICH guidelines in relation to clinical trials. If not already familiar, become familiar with institution Policy and Procedures with particular emphasis in conducting multiple clinical research trials.

  • Monitor and coordinate multiple research projects in order to assess the need for and to implement strategies to ensure the conduct of quality research, the achievement of expected time lines and deliverables, and the efficient use of human and practical resources.

  • Troubleshoot problems at all stages of project development and implementation and assist with modifying protocol or project procedures to address challenges.

  • Ensure protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.

  • Work as a member of the clinical research team with positive and timely written and verbal communication, including sharing information up, down and laterally.

  • Shows initiative to identify and implement ways to improve job and surroundings

  • Works in conjunction with a mentor to develop necessary skills to complete assignments and tasks.

  • Seeks supervision appropriately.

  • Plans work in a manner that allows timely completion of all assignments and tasks.

  • Demonstrates accuracy in all details.

  • Develop and maintain knowledge of institutional protocol submission procedures and requirements.
  • Maintain a processing and tracking system for all protocol related paperwork.
  • Manages low complexity trials after completion of orientation.
    • Externally according to International Air Transport Association (IATA) requirements.
    • Optimizes the safety of research subjects by monitoring and reporting any adverse events to the investigators and other members of the study team.
    • Participates in required teleconferences, on site meetings and off site investigator meetings, as required.

Hosts site initiation visits and monitoring or auditing visits.

Regulatory Track Associate Research Coordinator

  • Works under the supervision of the Portfolio Supervisor with direction from Study Investigators and the Clinical Trials Manager.
  • Works in conjunction with a mentor to develop the skills to assume more responsibility and workload.
  • Manages low complexity trials after completion of orientation.
  • Performs protocol specific duties required per the research protocol, including:

    • Primary emphasis of work is on the maintenance of studies after activation.

    • Coordinate the preparation and submission of amendments and IND safety reports to appropriate committees, including DSMC, C/PRMC, and COH IRB, WIRB, CIRB, and other committees as necessary, including editing of informed consent document.

    • Working in coordination with the Project Coordinator, tracks submission of IND safety reports for the regulatory binder

    • Interact with appropriate institutional staff to ensure that the amendment approval process is completed in a timely manner.

    • Keep the Senior Regulatory Coordinator, Portfolio Supervisor, the assigned research team, PIs and CTO leadership teaminformed of issues with the amendment status

    • Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., C/PRMC, IRB, IBC) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration and other COH offices/department involved in the study maintenance.
    • Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.
    • Inform sponsors and collaborators of regulatory status of protocols at least monthly

    • Provide updates to the Disease Teams on the regulatory status of all protocols, no less frequently than monthly.

Data Track Associate Research Coordinator

  • Works under the supervision of the Portfolio Supervisor with direction from Study Investigators and the Clinical Trials Manager.

  • 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, including responding to any requests for data clarification, and maintains all necessary source documents.

    • Obtains data 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.

    • Identifies and communicates important protocol and data management issues or problems to the portfolio supervisor in a timely manner.

Minimum Education and Skills Required for Consideration:

  • Bachelor’s degree. Experience may substitute for minimum education requirements (Associate Degree plus minimum of 2 years’ experience).

  • At least one year of experience related to the management and conduct of 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.

  • Computer skills including MS Office products, Internet, and general computer proficiency required.

Preferred Education and Skills:

  • Certification in Clinical Research, SOCRA, or ACRP certification preferred.

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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