Clinical Research Coordinator I - Ora

Please note that this role is not for a position at Ora, Inc.  This role is for a position at the company Andover Eye Associates, which is a close working partner of Ora, Inc.

POSITION TITLE: Per Diem, Clinical Research Coordinator I

DEPARTMENT:  Clinical Studies

LOCATION: On-site,Andover, MA

Revolutionizing clinical trials with unparalleled expertise, patient-focused innovation, and a commitment to delivering results that advance medical breakthroughs

At Andover Eye Institute, our mission is to lead the future of eye care through innovative clinical trials and groundbreaking research. We are committed to advancing the understanding and treatment of ophthalmic conditions by exploring new frontiers in medical science. Our team of experienced and compassionate professionals works closely with participants and sponsors, ensuring that each clinical trial is conducted with the utmost care, precision, and attention to detail.

The Role:

Andover Eye Institute Per Diem, Clinical Research Coordinator I (CRC I) has close relationships with the subjects who participate in our clinical trials. Our CRC I's will collect, record, and organize research information for clinical projects, while ensuring compliance with clinical project protocol and overall clinical objectives. Our CRC I's will partner with Clinical Research Coordinators and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators.

What You'll Do:

• Performs clinical skills identified in the SOP at study visits.
•  Maintains protocol compliance during clinical projects.
•  Be compliant with SOP, ICH-GCP and regulations.
•  Login time and expenses in a timely manner, follow the guidelines and company expense policy.
•  Participates in study start-up activities such as putting together charts, pulling patient charts, ensuring site cleanliness.
•  Performs patient screening, recruitment, and enrollment.
•  Create study documents as assigned.
•  Maintains study documents, including source documentation, case report forms, and regulatory documentation.
•  Provide Quality Control of documents as required.
• Enters data into electronic database and resolves data queries.
•  Adhere to all aspects of Andover Eye Institute quality system.
•  Adhere to all essential systems and processes that are required at Andover Eye Institute to maintain compliance to Andover Eye Institute data integrity & business ethics and regulatory requirements.
•  Clear and sustained demonstration of Andover Eye Institute 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) Emergency Medical Technician 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:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • 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 faster, individual, team and company growth.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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