Stanford University School of Medicine
Clinical Research Coordinator Associate (Hybrid Opportunity)
Stanford University School of Medicine, Stanford, California, United States, 94305
Overview
Stanford University is seeking a Clinical Research Coordinator Associate (CRCA) to join the Division of Pulmonary, Allergy, and Critical Care Medicine (PACCM). This position is hybrid eligible and focuses on coordinating moderately complex aspects of multiple pulmonary research protocols, including industry-sponsored, NIH and PI-initiated investigational drug clinical trials as well as blood and tissue banking registries. The role has a focus on Non-Tuberculous Mycobacterial (NTM) Lung Disease, Idiopathic Pulmonary Fibrosis (IPF), and Progressive Pulmonary Fibrosis (PPF), with potential involvement in other lung disease study areas. The CRCA will work under the general direction of PACCM principal investigators and the Clinical Research Manager.
Responsibilities
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out.
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
Coordinate collection of study specimens and processing.
Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
Participate in monitor visits and regulatory audits.
Qualifications & Experience
Desired Qualifications: Experience with interventional drug treatment trials; clinical experience with patients with pulmonary disease; completion of a clinical trials certification program or related courses.
Education & Experience (required): Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
Knowledge, Skills And Abilities (required): Strong interpersonal skills; proficiency with Microsoft Office; knowledge of medical terminology.
Certifications & Licenses: Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG.
Physical Requirements
Frequently stand, walk, twist, bend, stoop, and use fine motor skills.
Occasionally sit, reach above shoulders, perform desk-based computer tasks, and lift/carry up to 40 pounds.
Rarely kneel, crawl, climb ladders, or lift/carry 40 pounds or more.
Working Conditions
Position may require work with hazardous materials and exposure to chemicals, blood, body fluids or tissues, and risk of exposure to contagious diseases.
Extended or unusual work hours may be required based on research requirements and business needs.
Pay and Benefits The expected pay range for this position is $34.56 to $40.30 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as the scope and responsibilities of the position, qualifications, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the rewards package. The Cardinal at Work website provides detailed information on Stanford’s benefits and rewards. Specifics about the rewards package for this position may be discussed during the hiring process.
Workplace Culture and Compliance Why Stanford is for You and Benefits sections outline the university’s culture, safety commitments, and available resources. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Applicants requiring reasonable accommodations should contact Stanford University Human Resources.
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Stanford University is seeking a Clinical Research Coordinator Associate (CRCA) to join the Division of Pulmonary, Allergy, and Critical Care Medicine (PACCM). This position is hybrid eligible and focuses on coordinating moderately complex aspects of multiple pulmonary research protocols, including industry-sponsored, NIH and PI-initiated investigational drug clinical trials as well as blood and tissue banking registries. The role has a focus on Non-Tuberculous Mycobacterial (NTM) Lung Disease, Idiopathic Pulmonary Fibrosis (IPF), and Progressive Pulmonary Fibrosis (PPF), with potential involvement in other lung disease study areas. The CRCA will work under the general direction of PACCM principal investigators and the Clinical Research Manager.
Responsibilities
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out.
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
Coordinate collection of study specimens and processing.
Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
Participate in monitor visits and regulatory audits.
Qualifications & Experience
Desired Qualifications: Experience with interventional drug treatment trials; clinical experience with patients with pulmonary disease; completion of a clinical trials certification program or related courses.
Education & Experience (required): Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
Knowledge, Skills And Abilities (required): Strong interpersonal skills; proficiency with Microsoft Office; knowledge of medical terminology.
Certifications & Licenses: Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG.
Physical Requirements
Frequently stand, walk, twist, bend, stoop, and use fine motor skills.
Occasionally sit, reach above shoulders, perform desk-based computer tasks, and lift/carry up to 40 pounds.
Rarely kneel, crawl, climb ladders, or lift/carry 40 pounds or more.
Working Conditions
Position may require work with hazardous materials and exposure to chemicals, blood, body fluids or tissues, and risk of exposure to contagious diseases.
Extended or unusual work hours may be required based on research requirements and business needs.
Pay and Benefits The expected pay range for this position is $34.56 to $40.30 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as the scope and responsibilities of the position, qualifications, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the rewards package. The Cardinal at Work website provides detailed information on Stanford’s benefits and rewards. Specifics about the rewards package for this position may be discussed during the hiring process.
Workplace Culture and Compliance Why Stanford is for You and Benefits sections outline the university’s culture, safety commitments, and available resources. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Applicants requiring reasonable accommodations should contact Stanford University Human Resources.
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