Clinical Research Associate CRA in San Diego (non-remote) Our consultancy is expanding and we have a great opportunity for a local San Diego CRA with oncology, metabolic or CNS experience working for a CRO. The site monitoring is an on-site model. We are looking for experienced CRAs, who currently live in San Diego. The duration is 3 to 12 months, and it may be renewable. We have multiple openings at 0.10-1.0 FTE unblinded and blinded CRA roles. Please read the rest of the job info, and do not apply if you lack prior experience. If you are tired of getting used up by companies and want to work for yourself alongside our clinical research group - look no further. Our group is rapidly expanding, works to enhance our clients' culture by providing experienced professionals - and we are all passionate about doing life-changing clinical research. We want to be in business with like-minded people. If you meet the qualifications and this sounds like you, apply today! Please fill out the intro application survey sent via email after you apply. Thank you! Responsibilities: • CRA San Diego (On-site) • Interfaces with 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 multiple openings at 0.10-1.0 FTE unblinded and blinded CRA roles • May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, and 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 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, 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, study plans, mentor staff, review line listings, and/or conduct staff training/sign off visits • May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, and 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 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, 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, study plans, mentor staff, review line listings, and/or conduct staff training/sign off visits Qualifications: • 3 years or more as a CRA with site monitoring responsibility AND 1 year or more in Oncology Monitoring OR • 3 years or more as a CRA with site monitoring responsibility AND 1 year or more in either: Phase 1, a complex indication with in-patient monitoring, OR metabolic studies OR • 5 years or more as a CRA with site monitoring responsibility AND 3 years or more in CNS Monitoring AND • The candidate possesses a 4-year university degree, ideally in a scientific field • In lieu of a 4-year university degree, a candidate with 7 or more years of relevant clinical research experience, and with 5 years of monitoring in a complex indication (in-patient, oncology, phase 1, etc.) may be considered • Must have working rights in the United States • Must be located within the West Coast • The candidate must have availability the next 3 to 12 months • 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: $55 - $100 hourly

• CRA San Diego (On-site) • Interfaces with 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 multiple openings at 0.10-1.0 FTE unblinded and blinded CRA roles • May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, and 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 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, 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, study plans, mentor staff, review line listings, and/or conduct staff training/sign off visits • May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, and 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 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, 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, study plans, mentor staff, review line listings, and/or conduct staff training/sign off visits