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.
Employment Type: Full Time.
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 AND RESPONSIBILITIES include the following:
- 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.
QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
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.