Senior Clinical Research Coordinator
Job ID: 14943
Job Title: Sr. Clinical Research Coordinator
THIS POSITION SUPPORTS OUR EXPANSIVE CLINICAL TRIALS PROGRAM!
About our Clinical Trials:
We're aggressively pursuing ways to help our patients right now not years from now. That focus puts City of Hope among the worldwide leaders in administering clinical trials. In a given year, City of Hope conducts more than 400 clinical trials enrolling more than 6,000 patients. To learn more about our clinical trials, please visit http://clinicaltrials.coh.org/
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 investigators.
Basic Requirements for Senior Research Coordinators:
- 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 surrounding
- Seeks supervision appropriately.
- Participates as a mentor to new employees and associate research coordinators
- 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 trials of all level of complexity.
Minimum Education, and Skills Required for Consideration:
- Must have a Bachelor's Degree
- Must be a have valid SOCRA or ACRP certification
- Must have at least six or more years of experienceas a Clinical Research Coordinator.
- Ability to access data in computer data bases, compile data, proofread documents, research information, troubleshoot problems, use computer packages and use word-processing software.
Preferred Education and Skills:
- Master's Degree
- Oncology experience preferred.
- There are positions available across multiple disease teams that can include: Diabetes, CAR T Cell Therapy, GI, GU, Lymphoma, Pediatrics, Leukemia, Lung, Breast, Myeloma, Solid Tumor and other Oncological specialties.
About City of Hope
City of Hope is an independent research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as one of only 49 comprehensive cancer centers, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the world.
City of Hope is located in Duarte, California, just northeast of Los Angeles, withcommunityclinicsthroughout Southern California. It is ranked as one of "America's Best Hospitals" in cancer by U.S. News & World Report . Founded in 1913, City of Hope is a pioneer in the fields ofbonemarrowtransplantation, diabetes and numerous breakthroughcancerdrugsbased on technology developed at the institution.
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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