City of Hope Senior Research Coordinator in Duarte, California
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 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.
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 Supervisorwith direction from Study Investigators and the Clinical Trials Manager.
Performs protocol specific duties required per theresearch protocol, including:
Abstracts data from the medical record and completespaper and electronic case report forms, including responding to anyrequests for data clarification, and maintains all necessary sourcedocuments.
Obtains data from outside facilities as needed
Responds to all requests for data clarifications
Point person to receive AE notification from studyteam
Collaborates with the Clinical Tract RC to submitcontinuing reviews, AEs, Deviations and UPs appropriately.
Knowledgeable of sponsor requirements for timelinessof data and response to queries
Ensures data collection is available per contractobligations at the time of monitoring visits.
Fulfills sponsor requirements related to reportableinformation, including: adverse events, unanticipated problems, otherinformation required by the sponsor protocol.
Participates in audits and monitor visits for assignedstudies, and as requested.
Identifies and communicates important protocol and datamanagement issues or problems to the portfolio supervisor in a timelymanner.
Communicate with appropriate individual(s) regardingupcoming deadlines, data locks, monitoring visits and audits.
Collaborates with OIDRA on IND reports for investigatorinitiated trials.
Expert in Good Clinical Practices, Food and DrugAdministration Rules and Regulations, NIH guidelines, HIPAA regulationsand ICH guidelines in relation to clinical trials. Very familiar with institutionPolicy and Procedures with particular emphasis in conducting multipleclinical research trials.
Monitor and coordinate multiple research projects inorder to assess the need for and to implement strategies to ensure theconduct of quality research, the achievement of expected time lines anddeliverables, and the efficient use of human and practical resources.
Troubleshoot problems at all stages of projectdevelopment and implementation and assist with modifying protocol orproject procedures to address challenges.
Ensure protocol adherence by understanding,communicating and making sure the study parameters are ordered and carriedout per protocol requirements.
Work as a member of the clinical research team withpositive and timely written and verbal communication, including sharinginformation up, down and laterally.
Shows initiative to identify and implement ways toimprove job and surroundings
Seeks supervision appropriately.
Participates as a mentor to new employees and associateresearch coordinators
Plans work in a manner that allows timely completion ofall assignments and tasks.
Develop and maintain knowledge of institutionalprotocol submission procedures and requirements.
Demonstrates accuracy in all details.
Maintain a processing and tracking system for allprotocol related paperwork
Manages trials of all level of complexity.
Basic education, experience andskills required for consideration:
Must have a Bachelor’s degree.
Must have at least five years of experience related tothe management and conduct of clinical trials in an academic setting.
Must have working knowledge of clinical trials,Federal, State, and Local Regulations, IRB requirements, consent form andprotocol development.
Must have excellent skills in time management,prioritization, and multi-tasking.
Must have strong organizational skills.
Must have the ability to practice independently, strongverbal and written communication skills, organizational and criticaljudgment skills, and be able to interact effectively with co-workers andcustomers. Strong attention to detail.
Must be proficient in MS Office
- Must have a SOCRA or ACRP Certification in ClinicalResearch
Preferred education experience andskills:
Advanced degree in healthcare or medical field.
Previous experience working with Oncology relatedClinical Trials
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.
Job: Clinical Research
Title: Senior Research Coordinator
Requisition ID: 13688-TBE
City of Hope
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