Clinical Research Coordinator - Remote

About City Of Hope

City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. City of Hope’s affiliated family of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn.

Position Summary:

The Clinical Trial Office (CTO) assists COH investigators with the management of research studies involving human subjects. Under the direction of the Vice President, Clinical Research Operations 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. This is a work from home, remote position.

Clinical Research Coordinators (CRC) are responsible for maintaining data integrity of multiple assigned research studies. They are responsible for abstracting data, completing case report forms (CRFs) 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. CRCs are also responsible for ensuring compliance to the research protocol and all appropriate regulations. It is their responsibility to create and maintain the research record and maintenance of patient information in the clinical trials management system (CTMS).

The CRC must be well versed in Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, NIH guidelines, and HIPAA regulations. If not already, s/he must become familiar with institutional policy and procedures regarding conducting multiple clinical research trials. Develop and maintain knowledge of institutional protocol submission procedures and requirements. The CRC must be able manage multiple medium to high complexity research projects ensuring quality research conduct, achievement of expected time lines and deliverables, and efficient use of human and practical resources. The CRC must be able to work as a member of the clinical research team with positive and timely written and verbal communication, including sharing information up, down and laterally. This includes communicating protocol deviations or issues with study execution. They are to ensure protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements. The CRC seeks supervision appropriately, prioritizes appropriately, completes work in a timely manner and demonstrates accuracy in all details.

Key Responsibilities include:

Protocol Compliance

• Assembles lab kits and other supplies in preparation to obtain required bio-specimen samples and transports to appropriate laboratories for processing; ships samples externally according to IATA requirements.
• Ensures all protocol procedures are ordered and completed as specified in the protocol.
• Optimizes the safety of research subjects by ensuring any adverse events (AE) are appropriately reported to the sponsor, study team and institution according to protocol and regulatory requirements.

Data Management

• Responds to all requests for data clarifications of assigned studies.
• Meets contractual or institutional requirements for timeliness of data entry and query resolution.
• Point person to receive AE notification from study team and ensures AE is followed up and/or resolved, as applicable.
• Ensures data accuracy with source documentation.
• Obtains data, including images, specimens and medical records, from outside facilities, as needed.
• Abstracts data from the medical record and completes paper and electronic CRFs including responding to any requests for data clarification.
• Fulfills sponsor requirements related to reportable information, including: AE, unanticipated problems, other information required by the sponsor protocol.
• Maintains all necessary patient source documents for assigned studies.
• Ensures documentation processes are followed according to GCP.

Administration

• Ensures all patients, for assigned studies, are entered into the CTMS according to COH policies and status is correct.
• Participates in required teleconferences, study meetings, both on and off-site, as required.
• Schedules and participates in interim monitoring visits (IMV) for source data verification (SDV).
• Responds to colleagues, faculty, leaders and sponsors in a timely manner.
• Attends Disease/Modality Team meetings to ensure any issues are communicated to the team.
• Reviews monitoring reports for assigned studies, determines any discrepancies and resolves outstanding data issues identified by the monitor.
• Assist Clinical Research Billing (CRB) with resolving outstanding data issues or inquiries for financial concerns.
• Identifies and communicates important protocol and data management issues or problems to the PI and supervisor in a timely manner.
• Updates patient data in the CTMS to ensure appropriate patient calendars are utilized.
• Participate in the validation of the Epic treatment plans and CTMS calendars for assigned studies.
• Assist the Epic Protocol Content Administrators (PCAs) with questions regarding the protocol procedural requirements, including lab tests, EKG’s or imaging.
• Participates in audits and monitor visits for assigned studies, and as requested.
• Adheres to IMV policies of COH.

Other Related Duties As Assigned Or Requested

• Job descriptions are not intended and should not be construed to be exhaustive lists of all responsibilities, skills, efforts or working conditions associated with a job.
• Serve as a resource to other staff regarding assigned protocols.
• Participate in at least 1 CTO working group/committee each year.
• Other duties as assigned.
• Identifies and participates in professional development activities and opportunities.
• Participates in study team meetings.
• Participate in staff meetings.

Basic education, experience and skills required for consideration:

• Two or more 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.
• Bachelor’s Degree. Experience may substitute for minimum education requirements. (i.e. Associate Degree plus two years of experience.)

Preferred Education:

• Master’s Degree

Pref. Certification/Licensure:

• SOCRA or ACRP certification preferred

Skills/Abilities:

• Troubleshoot problems
• Access data in computer data bases
• 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.
• Research information
• Compile data
• Use word-processing software
• 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.
• Use computer packages
• 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.
• Proofread documents

Software:

• Microsoft products, Internet and general computer proficiency required.

Machines/Equipment:

• Eye Protection/Goggles
• Gown
• Mask
• Requires use of computer via keyboard, calculator, printer, photocopy machine, etc. Requires the use of push-button telephone set. Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)
• Non-Sterile Medical Gloves
• If responsible for specimen handling:
• Respirator
• Face Protection
• Sterile Medical Gloves
• Lab Coat or Apron

Working / Environmental Conditions:

• Work from home information here.

Physical Demands:

• Ability to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds. Ability to handle multiple tasks at once.

Additional Information:

• As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
• The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.

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 a disability.

Basic education, experience and skills required for consideration:

• Bachelor’s Degree. Experience may substitute for minimum education requirements. (i.e. Associate Degree plus two years of experience.)
• Two or more 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.

Preferred Education:

• Master’s Degree

Pref. Certification/Licensure:

• SOCRA or ACRP certification preferred

Skills/Abilities:

• Research information
• 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.
• Proofread documents
• Compile data
• Troubleshoot problems
• Access data in computer data bases
• 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.
• Use computer packages
• Use word-processing software
• 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.

Software:

• Microsoft products, Internet and general computer proficiency required.

Machines/Equipment:

• Non-Sterile Medical Gloves
• Face Protection
• Eye Protection/Goggles
• Sterile Medical Gloves
• Mask
• If responsible for specimen handling:
• Respirator
• Lab Coat or Apron
• Requires use of computer via keyboard, calculator, printer, photocopy machine, etc. Requires the use of push-button telephone set. Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)
• Gown

Working / Environmental Conditions:

• Work from home information here.

Physical Demands:

• Ability to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds. Ability to handle multiple tasks at once.

Additional Information:

• The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
• As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.

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 a disability.