Associate Regulatory Coordinator (Remote)
Job posting number: #7111274 (Ref:10018212)
Posted: January 25, 2023
Salary / Pay Rate: $25.27 - $39.17 / hour
Application Deadline: Open Until Filled
- Develop and maintain knowledge of institutional protocol submission procedures and requirements.
- Maintain a processing and tracking system for all protocol related paperwork.
- Collect and develop criteria information for protocol submission.
- Coordinate the preparation and submission of new studies to appropriate committees, including DSMC, C/PRMC, COH IRB, WIRB, CIRB and other committees as necessary, including drafting and/or editing of informed consent document.
- Interact with appropriate institutional staff to ensure that the protocol approval process is completed in a timely manner.
- Keep the Senior Regulatory Coordinator, RSS Manager, PI and research staff informed of issues with the protocol approval and activation
- Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., C/PRMC, IRB, IBC) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration and other COH offices/department involved in the study start up process.
- Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.
- Inform sponsors and collaborators of regulatory status of protocols at least monthly
- Provide back up to Regulatory Coordinator III in providing updates to Disease Teams on protocol status
- Prepare submission of the revision of existing protocol and consent documents to appropriate committees
- Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination
- Coordinate regulatory correspondence.
- Interact with appropriate institutional staff for amendments to clinical trials.
- Keep the PI and research staff informed of status of amendments
- Participate in research audits, as required.
- Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., C/PRMC, IRB, IBC) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration).
- Assist in maintaining Regulatory Binder for each study, including updating FDA Forms 1572 and Financial Disclosures as needed
- Liaise with Protocol Coordinators, investigators, study team and sponsors, as needed
- Attend department meetings and conferences.
- Attend approved off-site meetings and conferences.
- Supplement education as needed through use of reference materials, lectures, etc.
- Assist in the training and orientation of new clinical trials staff in regard to department policies and procedures for the conduct of clinical trials and the appropriate completion of data entry.
- Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department standard work and presented at weekly staff meetings.
- Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.
- 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.
- 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 oncology 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.
- 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 bloodborne 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.