Our CRO client is looking for an experienced oncology CRA contractor specifically, and only, within the country of Singapore. The study that the CRA will monitor is global, phase III, and in a solid tumor indication. We are not considering candidates who are from other countries outside Singapore. The assignment is only for a Sr. CRA who can contract with a foreign (US-based) company. The Sr. CRA will have up to 100% contract availability and needs to be experienced in monitoring solid tumor oncology studies. A valid candidate will already have 4 years or more as a CRA, at least 1 year in solid tumor oncology, and must have a high level of written & verbal English skills. You need to be able to write trip reports in English, speak with management in English, and work within the client's systems in English. The Sr. CRA contractor must have the legal capability to work in Singapore. A valid passport with the possibility of international travel is a bonus. We are not looking for current study coordinators or site-level staff even if you have an MD, PhD, or other terminal degree. Education does not pre-empt experience as a CRA. Applicants with no employment and no contracting experience as a CRA are automatically rejected. You must be a Sr. CRA with the required years of experience to apply. Responsibilities: • Oncology-experienced Sr. CRA who is based in either Singapore, Taiwan, or South Korea (remote with travel required to clinical research sites) • Interfaces with the study team to ensure timely initiation and completion of clinical trials • Responsible for the identification, evaluation, and qualification of investigators and sites • May prepare and submit essential document packages required for clinical site initiation • Performs on-site monitoring activities for clinical trials and escalates site issues to Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in the monitoring reports and follow-up correspondence • Reviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targets • We have three openings at ~1.0 FTE each • May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance • Ensure the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements • Identify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authorities. • Ensure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor study database for missing or discrepant data compared to the source record at the clinical site • Ensure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan) • Maintain the study blindly and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision • Attend investigators’ meetings, project team meetings, and teleconferences, as needed. • Understands and applies knowledge regarding local, state, and country regulations (i.e., TGA, etc.) and ICH-GCP • Maintain training on ICH-GCP, study protocol, and client procedures • May track regulatory documents may track recruitment, may evaluate study site quality and integrity, and may motivate assigned sites to meet client deadlines • May create study tools, and study plans, mentor staff, review line listings, and/or conduct staff training/sign-off visits Qualifications: • 4 years or more as a CRA with site monitoring responsibility AND 1 year or more in solid-tumor oncology monitoring as a traveling CRA. • The candidate possesses at minimum a bachelor / 4-year university degree, ideally in a scientific field • In lieu of a bachelor's degree or other 4-year university degree, a candidate with 7 or more years of relevant clinical research experience, and 5 years of monitoring in solid tumor oncology may be considered • Must have working rights in the country selected for monitoring (either Taiwan, South Korea, or Singapore). Do NOT apply if you are located in another country. • The candidate must have availability for this contract for the duration of the term (6-12 months depending on what is listed) • Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminology • Must be proficient at tactfully and succinctly managing intra-team communication, as well as interpersonal communication with the site Compensation: $65 - $90 per hour DOE

• Oncology-experienced Sr. CRA who is based in either Singapore, Taiwan, or South Korea (remote with travel required to clinical research sites) • Interfaces with the study team to ensure timely initiation and completion of clinical trials • Responsible for the identification, evaluation, and qualification of investigators and sites • May prepare and submit essential document packages required for clinical site initiation • Performs on-site monitoring activities for clinical trials and escalates site issues to Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in the monitoring reports and follow-up correspondence • Reviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targets • We have three openings at ~1.0 FTE each  • May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance • Ensure the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements • Identify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authorities. • Ensure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor study database for missing or discrepant data compared to the source record at the clinical site • Ensure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan) • Maintain the study blindly and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision • Attend investigators’ meetings, project team meetings, and teleconferences, as needed. • Understands and applies knowledge regarding local, state, and country regulations (i.e., TGA, etc.) and ICH-GCP • Maintain training on ICH-GCP, study protocol, and client procedures • May track regulatory documents may track recruitment, may evaluate study site quality and integrity, and may motivate assigned sites to meet client deadlines • May create study tools, and study plans, mentor staff, review line listings, and/or conduct staff training/sign-off visits