Inside Higher Ed
Clinical Research Coordinator Associate (1 Year Fixed-Term)
Inside Higher Ed, Stanford, California, United States, 94305
Overview
Clinical Research Coordinator Associate (1 Year Fixed-Term) Department: School of Medicine, Redwood City, California, United States. The Department of Orthopaedic Surgery conducts musculoskeletal research across subspecialties and aims to advance treatments for musculoskeletal injury and disease. The CRCA will oversee clinical studies within the PMR/Lifestyle Medicine division, working under supervision and collaborating with coordinators, research assistants, physicians, scientists, biostatisticians, residents, and medical assistants involved in spinal care research. The role requires strong communication and documentation skills and the ability to juggle competing project priorities and deadlines.
Responsibilities
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
Determine eligibility of and obtain 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, 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 (PI) regularly, ensuring patient safety and adherence to proper study conduct.
Clearly communicate to PI and research team regarding project status and any issues/barriers to project implementation.
Interact with lead biostatistician regularly, ensuring proper study implementation and data management.
Meet with PI and research manager regularly to refine project prioritization.
Juggle multiple open research projects while meeting deadlines for deliverables.
Respond to team communications (email, phone) in a timely and accurate manner.
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.
Conduct scientific and educational writing collaborating with the PI and researchers to research, develop, and disseminate evidence-based resources for both professional and lay audiences.
Other duties may also be assigned.
Qualifications 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.
Skills in scientific/health education writing are valued but not required.
Desired Qualifications
Excellent verbal and written communication skills in English required.
Prior experience with patients or research subjects is desired.
Certifications & Licenses Society of Clinical Research Associates or Association of Clinical Research Professionals 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 and write by hand, lift, carry, push, and pull objects up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects weighing more than 40 pounds.
Reasonable accommodation will be provided as required by law.
Working Conditions Occasional evening and weekend hours.
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. Specifics about benefits are discussed during the hiring process and are available on the Cardinal at Work site.
Equality, Diversity and Inclusion 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. The University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring accommodations for any part of the application or hiring process should contact Stanford University Human Resources.
Additional Information
Schedule: Full-time
Job Code: 1013
Employee Status: Fixed-Term
Grade: F
Requisition ID: 107271
Work Arrangement: On Site
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Clinical Research Coordinator Associate (1 Year Fixed-Term) Department: School of Medicine, Redwood City, California, United States. The Department of Orthopaedic Surgery conducts musculoskeletal research across subspecialties and aims to advance treatments for musculoskeletal injury and disease. The CRCA will oversee clinical studies within the PMR/Lifestyle Medicine division, working under supervision and collaborating with coordinators, research assistants, physicians, scientists, biostatisticians, residents, and medical assistants involved in spinal care research. The role requires strong communication and documentation skills and the ability to juggle competing project priorities and deadlines.
Responsibilities
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
Determine eligibility of and obtain 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, 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 (PI) regularly, ensuring patient safety and adherence to proper study conduct.
Clearly communicate to PI and research team regarding project status and any issues/barriers to project implementation.
Interact with lead biostatistician regularly, ensuring proper study implementation and data management.
Meet with PI and research manager regularly to refine project prioritization.
Juggle multiple open research projects while meeting deadlines for deliverables.
Respond to team communications (email, phone) in a timely and accurate manner.
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.
Conduct scientific and educational writing collaborating with the PI and researchers to research, develop, and disseminate evidence-based resources for both professional and lay audiences.
Other duties may also be assigned.
Qualifications 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.
Skills in scientific/health education writing are valued but not required.
Desired Qualifications
Excellent verbal and written communication skills in English required.
Prior experience with patients or research subjects is desired.
Certifications & Licenses Society of Clinical Research Associates or Association of Clinical Research Professionals 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 and write by hand, lift, carry, push, and pull objects up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects weighing more than 40 pounds.
Reasonable accommodation will be provided as required by law.
Working Conditions Occasional evening and weekend hours.
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. Specifics about benefits are discussed during the hiring process and are available on the Cardinal at Work site.
Equality, Diversity and Inclusion 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. The University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring accommodations for any part of the application or hiring process should contact Stanford University Human Resources.
Additional Information
Schedule: Full-time
Job Code: 1013
Employee Status: Fixed-Term
Grade: F
Requisition ID: 107271
Work Arrangement: On Site
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