Inside Higher Ed
Clinical Research Coordinator 2 (Fixed-term 2 years)
Inside Higher Ed, Stanford, California, United States, 94305
Clinical Research Coordinator 2 (Fixed‑Term, 2 Years)
Department of Anesthesiology, Perioperative, and Pain Medicine – Stanford University School of Medicine, Stanford, CA
We are seeking an experienced Clinical Research Coordinator 2 (CRC2) to conduct clinical research and independently manage complex projects focused on surgical and ICU patients, including studies on novel monitoring devices and acute kidney injury treatments.
Key Responsibilities
Oversee subject recruitment and study enrollment goals; develop and implement recruitment strategies and retention plans for long‑term clinical trials.
Oversee data management for research projects; develop and maintain systems to organize, collect, report, and monitor data collection; extract, analyze, and interpret data.
Develop project schedules, targets, metrics, and accountabilities; lead team meetings and prepare/approve minutes.
Formally supervise, train, and mentor new staff or students; assist with hiring, performance evaluations, and instruction on project work.
Audit operations (including laboratory procedures) to ensure compliance with regulations; provide leadership in implementing corrective actions and processes; monitor Institutional Review Board submissions and respond to requests.
Collaborate with principal investigators and study sponsors; monitor and report serious adverse events; resolve study queries.
Provide leadership in determining, recommending, and implementing improvements to policies and procedures; define best practices.
Develop study budget with staff and principal investigator; track milestones and invoice sponsors according to study contracts.
Ensure regulatory compliance; regularly inspect study documents to maintain ongoing compliance with FDA, HIPAA, FDA, and GCP requirements.
Work with principal investigator on Investigational New Drug applications; ensure Institutional Review Board renewals are completed.
May require working extended or unusual hours, including weekends and early or late shifts, as needed for research requirements.
Other duties may be assigned as necessary.
Education & Experience Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
Knowledge, Skills & Abilities
Strong interpersonal skills.
Proficiency with Microsoft Office and database applications.
Experience with research protocols and regulatory or governing bodies, including HIPAA, FDA, Institutional Review Board requirements, and Good Clinical Practices.
Knowledge of medical terminology.
Certifications & Licenses Society of Clinical Research Associates (SCRAC) or Association of Clinical Research Professionals (ACRP) certification is preferred.
Physical Requirements
Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
Occasionally sit, reach above shoulders, perform desk‑based computer tasks, use a telephone, write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork; rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
University will provide reasonable accommodation to employees with disabilities who require accommodation to perform essential tasks.
Working Conditions & Schedule
Work may occur in areas with hazardous materials, blood, or other biohazards; risk of exposure to contagious diseases; compliance with safety protocols is required.
Work hours may include extended or unusual schedules based on research requirements and business needs.
The expected pay range for this position is $86,248 to $100,158 per annum.
Additional Information Schedule: Full‑time Job Code: 4923 Employee Status: Fixed‑Term Grade: H Requisition ID: 107861 Work Arrangement: On Site
#J-18808-Ljbffr
We are seeking an experienced Clinical Research Coordinator 2 (CRC2) to conduct clinical research and independently manage complex projects focused on surgical and ICU patients, including studies on novel monitoring devices and acute kidney injury treatments.
Key Responsibilities
Oversee subject recruitment and study enrollment goals; develop and implement recruitment strategies and retention plans for long‑term clinical trials.
Oversee data management for research projects; develop and maintain systems to organize, collect, report, and monitor data collection; extract, analyze, and interpret data.
Develop project schedules, targets, metrics, and accountabilities; lead team meetings and prepare/approve minutes.
Formally supervise, train, and mentor new staff or students; assist with hiring, performance evaluations, and instruction on project work.
Audit operations (including laboratory procedures) to ensure compliance with regulations; provide leadership in implementing corrective actions and processes; monitor Institutional Review Board submissions and respond to requests.
Collaborate with principal investigators and study sponsors; monitor and report serious adverse events; resolve study queries.
Provide leadership in determining, recommending, and implementing improvements to policies and procedures; define best practices.
Develop study budget with staff and principal investigator; track milestones and invoice sponsors according to study contracts.
Ensure regulatory compliance; regularly inspect study documents to maintain ongoing compliance with FDA, HIPAA, FDA, and GCP requirements.
Work with principal investigator on Investigational New Drug applications; ensure Institutional Review Board renewals are completed.
May require working extended or unusual hours, including weekends and early or late shifts, as needed for research requirements.
Other duties may be assigned as necessary.
Education & Experience Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
Knowledge, Skills & Abilities
Strong interpersonal skills.
Proficiency with Microsoft Office and database applications.
Experience with research protocols and regulatory or governing bodies, including HIPAA, FDA, Institutional Review Board requirements, and Good Clinical Practices.
Knowledge of medical terminology.
Certifications & Licenses Society of Clinical Research Associates (SCRAC) or Association of Clinical Research Professionals (ACRP) certification is preferred.
Physical Requirements
Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
Occasionally sit, reach above shoulders, perform desk‑based computer tasks, use a telephone, write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork; rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
University will provide reasonable accommodation to employees with disabilities who require accommodation to perform essential tasks.
Working Conditions & Schedule
Work may occur in areas with hazardous materials, blood, or other biohazards; risk of exposure to contagious diseases; compliance with safety protocols is required.
Work hours may include extended or unusual schedules based on research requirements and business needs.
The expected pay range for this position is $86,248 to $100,158 per annum.
Additional Information Schedule: Full‑time Job Code: 4923 Employee Status: Fixed‑Term Grade: H Requisition ID: 107861 Work Arrangement: On Site
#J-18808-Ljbffr