Senior Clinical Research Coordinator

Location
Duarte, California
Salary
Competitive
Posted
January 17 2019
Ref
10000231
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. Under the direction of the Portfolio Supervisor, 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.

Senior Clinical Research Coordinators (SCRC) are responsible for serving as leads within their respective disease teams mentoring new staff, providing task level guidance to CRCs and ACRCs, and serving as subject matter experts in key CTO processes.

In addition to the lead activities, SRCs are 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. SCRCs are also 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:
  • Works under the supervision of the Portfolio Supervisor with direction from Study Investigators and the Clinical Trials Manager.
  • 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
  • Point person to receive AE notification from study team
  • Collaborates with the Clinical Tract RC to submit continuing reviews, AEs, Deviations and UPs appropriately
  • 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.
  • Communicate with appropriate individual(s) regarding upcoming deadlines, data locks, monitoring visits and audits.
  • Collaborates with OIDRA on IND reports for investigator initiated trials.
  • Expert in Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations and ICH guidelines in relation to clinical trials. Very 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

  • Seeks supervision appropriately.
  • Participates as a mentor to new employees and associate research coordinators


Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Performs other related duties as assigned or requested.

The performance for all expected outcomes is measured by observation by supervisor, reports from faculty and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires one to anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform any necessary tasks, and to comprehend the goals of the department/program and take the initiative in making decisions and taking actions to further these goals.

Internal Contacts: Investigators, study team, Protocol Scientific Review and Monitoring Office (PSRMO), Data Safety and Monitoring Office (DSMO), Office of Human Research Subjects Protection (OHRSP), Office of Laboratory Research Protections (OLRP), Office of Safety and Data Quality, Radiation Safety Office (RSO), Office of IND Development and Regulatory Affairs (OIDRA), Clinical Trials Support Services (CTSS), Nursing Support, Investigators, Office of General Counsel (OGC), Research Compliance Office (RCO), Information Technology Services (ITS)

External Contacts: Pharmaceutical Companies, National Cancer Institute (NCI) and other NIH institutes, National Clinical Trials Network (NCTN), Department of Defense (DOD), Early Therapeutics Clinical Trials Network (ETCTN), Consortiums, Other participating institutions, Contract Research Organizations (CRO), WIRB and NCI CIRB and other external IRBs.

The following shared, organization-wide competencies describe the desired behaviors that will facilitate success at City of Hope:

1. Communication - Expresses ideas clearly and constructively (written and spoken, upward and downward, one-on-one and with groups).

2. Customer Service - Seeks to understand customer needs and works to exceed customer expectations (internal and external).

3. Initiative - Looks for opportunities to improve performance; manages time, work, and relationships effectively and efficiently.

4. Professionalism - Treats others with respect; abides by the institutional values; displays a positive and cooperative attitude; adheres to the workplace Code of Conduct and compliance policies.

5. Stewardship - Identifies efficiencies to reduce redundancy and/or elimination of tasks resulting in savings of cost, resources, and or/time.

6. Teamwork - Works proactively and collaboratively with others to streamline work and achieve mutual goals.

Basic education, experience and skills required for consideration:
* Bachelor's degree. *
  • Minimum of five years of experience related to the management and conduct of oncology clinical trials in an academic setting. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
  • Certification in Clinical Research, SOCRA or ACRP Certification


Preferred education experience and skills:
  • Advanced degree in healthcare or medical field.
  • Excellent skills in time management, prioritization, and multi-tasking required. Strong organizational skills Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and be able to interact effectively with co-workers and customers. Strong attention to detail. Ability to focus on task is essential.
  • Be clearly understood by verbal communication in face-to-face encounters and by telephone. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis.
  • Strong command of the English language, including spelling, writing, and verbalizing and ability to communicate well verbally and in writing. Must be able to read, interpret, and process large quantities of printed information. Foster/promote a positive image and professional appearance. Sensitivity to intercultural relations. Sensitivity to the maintenance of confidentiality.
  • Access data in computer data bases
  • Compile data
  • Proofread documents
  • Research information
  • Troubleshoot problems
  • Use computer packages
  • Use word-processing software


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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