Ora · 23 hours ago
Clinical Research Coordinator I
Newport Beach, CA
Full-time
Hybrid
Entry Level
1+ years expOra is the world’s leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research. The Clinical Research Coordinator I will travel to clinical sites, conduct research, and ensure compliance with clinical project protocols while maintaining relationships with participants in clinical trials.
BiotechnologyConsultingHealth CareLegalPharmaceutical
Responsibilities
Participate in a 3 week-long introductory onboarding (part virtual, part in person) to prepare to learn and demonstrate mastery in various introductory skill sets required to begin clinic work
Travel to research sites as assigned for study visits to prepare for or continue clinical study conduct
Participate in study start-up activities such as putting together charts, pulling patient charts, ensuring site cleanliness
Contribute to and maintain study documents, including source documentation, case report forms, and regulatory documentation
Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments
Prioritize and deliver an exceptional subject experience, putting subject safety and protocol adherence to the forefront of your work
Collaborate with on-site staff, whether they be other Ora team members or clinic-based staff and Investigators
Performs patient screening, recruitment, and enrollment
Perform clinical skills identified in the SOP at study visits
Participate in various parallel and compounding trainings to continue advancement of required clinic skills
Maintain protocol compliance during clinical projects and adherence to work instructions and discretion in handling intellectual property
Remain compliant and timely with SOP, ICH-GCP and regulations
Enter and submit time sheets and expenses related to site travel in a timely manner, following the company expense policy
Prompt submission of work availability on a monthly basis
Enter data into electronic database and resolves data queries
Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary
Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements
Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors
Responsibilities may differ from the above based on the specific needs of the business
Qualification
Required
Bachelor's degree in Life Sciences OR 1-year experience in a clinical setting
Participate in a 3 week-long introductory onboarding (part virtual, part in person) to prepare to learn and demonstrate mastery in various introductory skill sets required to begin clinic work
Travel to research sites as assigned for study visits to prepare for or continue clinical study conduct
Participate in study start-up activities such as putting together charts, pulling patient charts, ensuring site cleanliness
Contribute to and maintain study documents, including source documentation, case report forms, and regulatory documentation
Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments
Prioritize and deliver an exceptional subject experience, putting subject safety and protocol adherence to the forefront of your work
Collaborate with on-site staff, whether they be other Ora team members or clinic-based staff and Investigators
Performs patient screening, recruitment, and enrollment
Perform clinical skills identified in the SOP at study visits
Participate in various parallel and compounding trainings to continue advancement of required clinic skills
Maintain protocol compliance during clinical projects and adherence to work instructions and discretion in handling intellectual property
Remain compliant and timely with SOP, ICH-GCP and regulations
Enter and submit time sheets and expenses related to site travel in a timely manner, following the company expense policy
Prompt submission of work availability on a monthly basis
Enter data into electronic database and resolves data queries
Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary
Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements
Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors
Preferred
Previous experience as a research coordinator is strongly preferred
Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications is strongly preferred
Medical skills and/or certifications such as (CPT) certified phlebotomist technician, (EMT) Emergency Medical Technician is preferred
This role requires a flexible schedule, including weekend availability, and the ability to travel domestically as needed
A team player attitude with a strong interest in clinical studies and enjoy interacting with patients
Benefits
Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.
Company
Ora
Ora is an ophthalmic clinical research and product development firm.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Paul Colvin
Chief Operating Officer
Aron Shapiro
Sr. Vice President, Asset Development & Partnering
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