LPO CENTRAL MONITOR

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The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being, and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally, and internationally.

PHI was distinguished as one of the top 50 “Best Non-Profit Organizations to Work For” by the Non-Profit Times in a national search.

Position Summary

The Children’s Oncology Group (COG), a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The COG unites more than 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Our goal is to cure all children and adolescents with cancer, reduce the short and long-term complications of cancer treatments, and determine the causes and find ways to prevent childhood cancer.

The LPO Central Monitor, reporting to the Manager of Quality Assurance and Audit, will be responsible for central monitoring of NCI sponsored clinical trials of all phases, as dictated by the study specific monitoring plan. In collaboration with COG study committees and teams, they will receive and review study protocols and case report forms. Source documents will be reviewed for completeness and accuracy and monitoring reports will be drafted as necessary. This position will interface with site personnel at COG institutions in issuing queries and following through to resolution. This position will also be responsible for reviewing reported protocol deviations.

This is a regular, remote, full time, position.

Full salary range for this position: $62,968 to $90,167 per year. The typical hiring range for this position is from $62,968 (minimum) to $76,568 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as budget availability.

Essential Duties & Responsibilities

• Conduct monitoring of study data, as dictated by the study monitoring plan, including, but not limited to, reviewing informed consent, eligibility criteria, and endpoint data utilizing case report forms, medical records/reports, laboratory data, and other source documentation used to produce study data.
• Coordinate activities related to monitoring, including but not limited to, start-up, data monitoring, documentation/tracking of progress, and drafting reports and escalating issues as appropriate.
• Work across departments to facilitate monitoring activities such as central monitoring plan development, appropriate set up of databases, and receipt and triaging of source documents in a timely manner.
• Open queries and follow up with sites/CRAs to resolution. Verify that corrections to the CRFs are made, if applicable.
• Maintain records of all correspondence, monitoring reports and other written documentation in accordance with operating procedures.
• Generate monitoring reports, summarizing the findings of all protocol deviations, discrepancies, and incorrect or missing data.
• Report protocol deviations, unanticipated problems, and discrepancies in Serious Adverse Events (SAE) reporting to internal departments/committees as appropriate.
• Work cooperatively with clinical research staff and investigators to address concerns and to communicate findings that can lead to improved clinical trial performance and/or compliance.
• When direction is needed, serve as a point of contact for sponsors, principal investigators, CRAs, and study committees.
• Process and track submitted protocol deviations through Medidata Rave.
  • Coordinate reviews by QA leadership
  • Open queries and work with site staff to resolution
  • Complete data entry requirements to document review
• Coordination of COG’s regulatory responsibilities when serving as the National Coordinating Center for international sponsored academic trials.
• At the discretion of the QA and Audit Director, assist in other day-to-day operational tasks related to QA and audit.
• Serve as a back-up for QA and Audit department staff as necessary.
• Travel overnight to COG Group Meetings and any other business related meetings.
• Perform other duties as assigned.

Minimum Qualifications

• 3 years related experience, with experience in clinical research and/or clinical regulatory compliance.
• Bachelor’s degree in science, nursing or related field, or substitute with four additional years of related experience.

Other Qualifications

• Knowledge of Good Clinical Practices; Code of Federal Regulations relating to clinical trials, and ICH Guidelines. Regulatory certification is preferred.
• Demonstrated organization and time management/prioritization skills with the ability to work independently are required.
• Must be competent in all components of Microsoft Office Suite.
• Excellent written and oral communications.
• Knowledge of disease state and an understanding of regulatory requirements, and study protocols and accompanying background information.
• In depth knowledge of GCP regulations, quality systems, quality assurance and quality control.
• Must have the ability to travel overnight to COG Group Meetings and any other business-related meetings.
• Master’s degree preferred.

FAIR LABOR STANDARDS ACT (FLSA) STATUS

This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal/state/local laws, the employee may be classified as nonexempt.

PHI WORKFORCE MANDATORY COVID-19 VACCINATION POLICY

Per the PHI Workforce Mandatory COVID-19 Vaccination Policy, it is a condition of employment for all domestic based employees to be fully vaccinated for COVID-19, unless they are granted a reasonable accommodation under applicable law.

New hires need to provide proof of full vaccination prior to their start date or apply for an exemption/accommodation within three business days after their start date. Depending on the circumstances, new hires who do not comply with this Policy, or who cannot be reasonably accommodated, will either have their employment suspended or terminated. Candidates who are non-compliant will have their offers rescinded.

EEO Statement

The Public Health Institute is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and to make all employment decisions so as to further this principle of equal employment opportunity. To this end, the PHI will not discriminate against any employee or applicant for employment because of race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and will take affirmative action to ensure that applicants are offered employment and employees are treated during employment without regard to these characteristics.

For further information regarding Equal Employment Opportunity, copy and paste the following URL into your web browser: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

ADA Statement:

The Public Health Institute is committed to providing access and reasonable accommodation in its services, programs, activities and employment for individuals with disabilities. To request disability accommodation in the application process, contact the Recruitment Team at least 48 hours in advance at Recruitment@phi.org.

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We’re so pleased the Public Health Institute is an organization you would like to work with. Do you have questions about this opportunity? If so, email our recruitment team at Recruitment@phi.org.

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