- Works under the supervision of the Portfolio Supervisor with direction from Study Investigators and the Clinical Trials Manager.
- Works in conjunction with a mentor to develop the skills to assume more responsibility and workload.
- 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
- 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.
- Knowledgeable in Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations and ICH guidelines in relation to clinical trials. If not already familiar, become 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.
- Works in conjunction with a mentor to develop necessary skills to complete assignments and tasks.
- Seeks supervision appropriately.
- 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.
- Manages low complexity trials after completion of orientation.
- Maintain a processing and tracking system for all protocol related paperwork.
Performs other related duties as assigned or requested.
- Bachelor’s degree. Experience may substitute for minimum education requirements (Associate Degree plus minimum of 2 years of experience).
- At least one year of experience related to the management and conduct of clinical trials in an academic setting, or six months experience as a Project Coordinator or Biospecimen Coordinator in the CTO. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
- Experience related to the management and conduct of clinical trials
- Certification in Clinical Research, SOCRA or ACRP certification preferred.
- 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
- Computer skills including MS Office products, Internet, and general computer proficiency required.
- Requires use of computer via keyboard, and operating facsimile machine, 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.)
- Lab Coat or Apron
- If responsible for specimen handling:
- Eye Protection/Goggles
- Face Protection
- Non-Sterile Medical Gloves
- Sterile Medical Gloves
- Academic Research Setting.
- Atmosphere and environment associated with an office setting
- Atmosphere and environment associated with patient care areas
- Tobacco free campus
- Subject to many interruptions
- Occasionally subjected to irregular hours
- Requires judgment that could affect image of City of Hope
- Occasional pressure due to deadline requirements
- Occasional travel required
- Exposed to material of a confidential nature on a regular basis
- Frequent pressure due to multiple calls and inquiries
- Contact with patients/patient families under varied circumstances
- Subject to regularly changing priorities and work assignments
- Subject to handling multiple tasks simultaneously.
- Possible exposure to infectious, radioactive or biohazardous agents
- Subject to varying and unpredictable situations
- Contact with patients/patient families under varied circumstances
- Subject to situations involving grief processes & related issues
- Possibly exposed to the risk of blood borne pathogens
- 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.
Salary / Pay Rate Information:
Pay Rate: $25.27 - $39.17 / hour
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 a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.