MultiCenter Clinical Research Monitor

Location
Monrovia, California
Salary
Competitive
Posted
October 14 2021
Ref
10013505
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 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 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary:

To be part of Research Operations at City of Hope, every employee should understand and share in the COH Vision, support our Mission, and live our Values. These values which include integrity, patient-centered, respect, accountability, and compassion-must guide what we do, as individuals and professionals, every day.

The Multicenter Research Operations office is part of the Safety and Data Quality department within the Research Protections unit under the Research Operations enterprise that provides support in the timely study start up, administration, and management of City of Hope investigator initiated multicenter trials. The primary responsibility of the Multicenter Research Operations office is to manage a portfolio of COH's investigator initiated multicenter trials to ensure standardized practices are compliant with all institutional and regulatory requirements. In addition to providing services to external sites, the Multicenter Research Operations office also provides limited Data Coordinating Center support with regards to central registration for COH patients

Essential Functions:

Eligibility Determination for COH and Participating Sites:
  • Perform review of eligibility case packets submitted to the COH Data Coordinating Center (DCC). Verify inclusion and exclusion criteria against source documentation to confirm patient eligibility for enrollment onto COH investigator initiated trials.
  • Manage registration tables for each assigned protocol to determine participant numbers, monitor Dose Level Toxicity assessments, track study accrual, and assign patients to different cohorts and dose levels.

External Site Activation Activities for Participating Sites:
  • Assist investigators in conducting site feasibility to ensure that site can appropriately accrue to the study prior to effort in site initiation as well as providing relevant information for budget development.
  • Collaborate with Clinical Trial Support Services (CTSS) to execute and track status of confidentiality agreements and sub site contracts/amendments.
  • Prepare and send study materials to external sites and request, review, and file regulatory documents prior to study activation.
  • Ensure that Site Initiation Visits (SIV) are coordinated in a timely fashion once contracts are executed.
  • Coordinate with the Clinical Research Coordinator for the assigned protocols and assist in the development of the site activation agenda, presentation, and training materials.
  • Schedule the SIV teleconference and ensure it is appropriately attended and maintain attendance documentation.
  • Assist clinical sites with account activation and provide eCRF training.

Study Maintenance for Participating Sites:
  • Liaise with the Clinical Trials Office (CTO), Office of Clinical Trials Auditing and Monitoring (OCTAM), Office of IND Development and Regulatory Affairs (OIDRA), Clinical Trial Support Services (CTSS), Clinical Trial Finance (CT Finance), Office of Clinical Protocol Development (OCPD), Data Safety and Monitoring Committee (DSMC) and Cancer Protocol Review and Monitoring Committee (CPRMC), Institutional Review Board (IRB), Principal Investigators (PIs), Biostatisticians, and serve as a primary point of contact for all study-related activities.
  • Serve as a subject matter expert to provide feedback on study-related documents, including (but not limited to), study protocol, informed consent template, study manuals, and Case Report Forms.
  • Maintain electronic systems for effective receipt, logging, tracking, and management of documents related to the management and monitoring of multicenter research. Such systems may include iRIS, eReg Binder, and OnCore as well as the case reporting form system.
  • Coordinate monthly conference calls with the COH study team and external sites to discuss study progress, enrollment issues, accrual status, etc., and issue meeting minutes in a timely manner.
  • Participate in team meetings with PIs to discuss study progress.
  • Assist in protocol development and protocol amendments.
  • Collaborate with Clinical Trials Finance (CT Finance) in reviewing monthly study accruals in the coordination of invoicing and budget management for participating sites.
  • Send updated study materials to sites as needed.
  • Perform other projects as assigned by the department Senior Manager, Multicenter Research Operations and/or Director, Safety and Data Quality.
  • Regulatory Responsibilities for Participating Sites:
  • Manage the Planned/Unplanned Deviation, Serious Adverse Event, and Unanticipated Problem reporting process (receive information/documents from sites, communicate with lead PI, prepare necessary FDA notification, and assist in the preparation of necessary site/sponsor notifications, etc.).
  • Support the regulatory and data collection aspects of the SIV for participating sites. Responsible for ensuring completion, collection, maintenance and management of all regulatory documents in eReg Binders.
  • Serve as a systems administrator in managing the central IRB for multicenter trials.
  • Perform periodic review of eReg Binders to ensure regulatory documents are current and coordinate with external sites to maintain current files.


Position Qualifications:

Minimum Education:
  • Bachelor's degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields.

Minimum Experience:
  • Two or more years of experience in Clinical Research

Preferred Experience:
  • Oncology and/or hematology clinical trials
  • Experience with multicenter clinical trials
  • Experience as a Clinical Research Coordinator/Associate
  • Experience as a regulatory affairs administrator
  • Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulatory requirements.

Preferred Training/Certification:
  • Trained and certified as a Clinical Research Associate by the Association of Clinical Research Professionals (ACRP) or as a Clinical Research Professional by the Society of Clinical Research Associates (SoCRA).

Skills/Abilities:
  • Exceptionally detail oriented
  • Excellent oral/written communication and organizational skills
  • Manage conflicting priorities and organize multiple tasks
  • Ability to efficiently review documents while focusing on specific data
  • Develop metrics, ancillary documentation, and training documents
  • Instruct/train others
  • Compose letters/memorandums/emails
  • Utilize resources to troubleshoot and solve problems
  • Foster and promote a positive image and professional appearance

Software and Systems:
  • Microsoft Office Suite (Outlook, Excel, Word, and PowerPoint), OnCore, iRIS, EPIC, CTOL, eCRF Systems, and other electronic data management systems

Working/Environmental Conditions:
  • Atmosphere and environment associated with an open office setting
  • Exposed to material of a confidential nature on a daily basis
  • Subject to occasional change in priorities and work assignments
  • Occasional need to work extended hours and/or flexible schedule
  • Tobacco-free workplace

Physical Demands:
  • Involves focused concentration on computer screens
  • Mostly sedentary work
  • Manual dexterity and mobility
  • Light physical effort (lift/carry up to 10 lbs.)
  • Occasional travel to other campuses to attend meetings
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.

  • Posting Date: Oct 14, 2021
  • Job Field: Clinical Research
  • Employee Status: Regular
  • Shift: Day Job

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