Ora
Overview
Join to apply for the
Clinical Research Coordinator I
role at
Ora POSITION TITLE:
Clinical Research Coordinator I DEPARTMENT:
Anterior Segment LOCATION:
Andover, MA Ora is the world’s leading full-service ophthalmic drug and device development firm. Our team guides clients across all phases of clinical research to efficiently bring new products and therapies to market. We focus on quality through our models, data solutions, and regulatory strategies, with a global presence across North America, Europe, Asia and Latin America. The Role
Ora’s Clinical Research Coordinator I (CRC) works with subjects in regional, domestic, and sometimes international clinical trials. The CRC travels with a team to clinical sites to conduct world-class research using proprietary methodologies and to prepare sites for success. Onsite, the CRC collects, records, and organizes research information for clinical projects while ensuring compliance with the protocol and overall objectives. The CRC collaborates with Clinical Research Coordinator IIs, Lead Clinical Research Coordinators (LCRC), and Clinical Project Managers (CPM) and cross-functions with internal and external teams. This position reports to a LCRC. What You’ll Do
Fulfill initial and continued training prior to performing tasks in clinic setting. Coordinate travel accommodations including hotel reservations, rental cars, and flights as needed in accordance with Ora’s Travel & Expense Policy. Perform trained clinical skills per protocol at and as delegated by site Principal Investigators study visits in accordance with Ora SOPs, WKIs, practicums, and GCPs/GDPs. Maintain protocol compliance during study conduct. Be compliant with SOP, ICH-GCP, OSHA, HIPAA, and other regulations as applicable. Participate in study start-up activities such as putting together charts, pulling patient charts, and ensuring site cleanliness. Perform patient screening, recruitment, and enrollment. Maintain study documents, including source documentation, case report forms, and regulatory documentation. Enter data into database and resolve data queries. Exhibit business acumen and professional etiquette in all aspects of clinic and staff operations including adherence to company dress code. Log time and expenses according to the guidelines of the company expense policy; properly indicating expense category and study allocation with accuracy. Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary. Perform as Clinic Supervisor and Quality Control Technician at study visits (at completion of training). Adhere to all aspects of Ora’s quality system. 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. What We Look For
Experience Needed for Role: Bachelor's degree in Life Sciences or 1-year experience in a clinical or lab setting including course work. Additional Skills and Attributes: Previous experience as a research coordinator strongly preferred. Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications strongly preferred. Advanced degree in related study preferred but not required. Medical skills and/or certifications such as CPT certified phlebotomist technician, EMT preferred. The ability to work a flexible schedule including weekends. A team player attitude with a strong interest in clinical studies and enjoy interacting with patients. Competencies and Personal Traits: Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work. IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again. Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes growth. Why We Do It: Seek meaning and purpose and a desire to be part of something bigger than yourself; we are creating vision beyond what we see at Ora. What We Offer
Well-Being: Comprehensive healthcare options (Medical, Dental, Vision) from day 1. Flexible PTO & Unlimited Sick Time: 14 company-paid holidays in addition. Financial: Competitive salaries with 401K plan with company match. Family Support Care: Adoption and fertility assistance; 16 weeks paid Parental Leave. Company Paid Life & Disability Insurance. Remote & Wellness Reimbursement. Employee Assistance Program: Support for you and your family. Career Development Opportunities. Global Team: Opportunities to work with colleagues across the globe. Impact: Opportunity to research new ophthalmic therapies that will impact patients globally. Benefit Eligibility:
Full-time employees of Ora working a minimum of 30 hours per week. Per diem workforce is eligible for Medical and Dental after 6 months of service with an average of 30 hours per week. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We are an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Ora is a global company with a diverse, inclusive culture that values respect, accountability, and work-life balance for every team member. Privacy Policy | Ora (oraclinical.com)
#J-18808-Ljbffr
Join to apply for the
Clinical Research Coordinator I
role at
Ora POSITION TITLE:
Clinical Research Coordinator I DEPARTMENT:
Anterior Segment LOCATION:
Andover, MA Ora is the world’s leading full-service ophthalmic drug and device development firm. Our team guides clients across all phases of clinical research to efficiently bring new products and therapies to market. We focus on quality through our models, data solutions, and regulatory strategies, with a global presence across North America, Europe, Asia and Latin America. The Role
Ora’s Clinical Research Coordinator I (CRC) works with subjects in regional, domestic, and sometimes international clinical trials. The CRC travels with a team to clinical sites to conduct world-class research using proprietary methodologies and to prepare sites for success. Onsite, the CRC collects, records, and organizes research information for clinical projects while ensuring compliance with the protocol and overall objectives. The CRC collaborates with Clinical Research Coordinator IIs, Lead Clinical Research Coordinators (LCRC), and Clinical Project Managers (CPM) and cross-functions with internal and external teams. This position reports to a LCRC. What You’ll Do
Fulfill initial and continued training prior to performing tasks in clinic setting. Coordinate travel accommodations including hotel reservations, rental cars, and flights as needed in accordance with Ora’s Travel & Expense Policy. Perform trained clinical skills per protocol at and as delegated by site Principal Investigators study visits in accordance with Ora SOPs, WKIs, practicums, and GCPs/GDPs. Maintain protocol compliance during study conduct. Be compliant with SOP, ICH-GCP, OSHA, HIPAA, and other regulations as applicable. Participate in study start-up activities such as putting together charts, pulling patient charts, and ensuring site cleanliness. Perform patient screening, recruitment, and enrollment. Maintain study documents, including source documentation, case report forms, and regulatory documentation. Enter data into database and resolve data queries. Exhibit business acumen and professional etiquette in all aspects of clinic and staff operations including adherence to company dress code. Log time and expenses according to the guidelines of the company expense policy; properly indicating expense category and study allocation with accuracy. Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary. Perform as Clinic Supervisor and Quality Control Technician at study visits (at completion of training). Adhere to all aspects of Ora’s quality system. 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. What We Look For
Experience Needed for Role: Bachelor's degree in Life Sciences or 1-year experience in a clinical or lab setting including course work. Additional Skills and Attributes: Previous experience as a research coordinator strongly preferred. Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications strongly preferred. Advanced degree in related study preferred but not required. Medical skills and/or certifications such as CPT certified phlebotomist technician, EMT preferred. The ability to work a flexible schedule including weekends. A team player attitude with a strong interest in clinical studies and enjoy interacting with patients. Competencies and Personal Traits: Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work. IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again. Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes growth. Why We Do It: Seek meaning and purpose and a desire to be part of something bigger than yourself; we are creating vision beyond what we see at Ora. What We Offer
Well-Being: Comprehensive healthcare options (Medical, Dental, Vision) from day 1. Flexible PTO & Unlimited Sick Time: 14 company-paid holidays in addition. Financial: Competitive salaries with 401K plan with company match. Family Support Care: Adoption and fertility assistance; 16 weeks paid Parental Leave. Company Paid Life & Disability Insurance. Remote & Wellness Reimbursement. Employee Assistance Program: Support for you and your family. Career Development Opportunities. Global Team: Opportunities to work with colleagues across the globe. Impact: Opportunity to research new ophthalmic therapies that will impact patients globally. Benefit Eligibility:
Full-time employees of Ora working a minimum of 30 hours per week. Per diem workforce is eligible for Medical and Dental after 6 months of service with an average of 30 hours per week. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We are an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Ora is a global company with a diverse, inclusive culture that values respect, accountability, and work-life balance for every team member. Privacy Policy | Ora (oraclinical.com)
#J-18808-Ljbffr