Clinical Research Coordinator I

Ora•Indianapolis, IN

5d•Hybrid

About The Position

Ora is the world's leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research to efficiently bring new products and therapies to market. With over 45 years of experience and more than 85 new product approvals, Ora utilizes refined pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies. The company has over 400 employees across North America, Europe, Asia, and Latin America and is expanding globally. The Clinical Research Coordinator I (CRC I) plays a crucial role in supporting ophthalmic clinical trials by working closely with study subjects and traveling to clinical sites. This role involves administering technician-based tasks, collecting and organizing subject data, ensuring compliance with protocols, and collaborating with experienced professionals and external teams.

Requirements

Bachelor's degree in Life Sciences OR 1-year experience in a clinical setting
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
Flexible schedule, including weekend availability
Ability to travel domestically as needed
Team player attitude with a strong interest in clinical studies and enjoy interacting with patients
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.
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.
Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.

Nice To Haves

Previous experience as a research coordinator
Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications
Medical skills and/or certifications such as (CPT) certified phlebotomist technician, (EMT) Emergency Medical Technician

Responsibilities

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 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.
Perform 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.
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.
Demonstrate Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.