Clinical Research Coordinator

OPHTHALMOLOGY (IN-OPTH-IUINA)

Indiana University (IU) School of Medicine is a national leader in medical research and education. With more than 60 academic departments and specialty divisions across 9 campuses statewide and strong clinical partnerships with Indiana's most advanced hospitals and physician networks, the school is continuously advancing its mission to prepare healers and transform health in Indiana and throughout the world.

Indiana University School of Medicine Department of Ophthalmology is committed to training tomorrow's ophthalmologists and to advancing treatments and prevention of eye diseases and vision disorders through research. The department has invested in talented scientists and faculty known for their clinical expertise. Work done within the department is guided by the core values of excellence, integrity, cooperation and respect for all individuals.

• Oversees day-to-day activities of the projects. Manages project staff's interaction with participants and data collection; assesses and ensures that staff follow protocols and standard operating procedures.
• Manages the recruitment of study participants according to approved methodologies; ensures that study staff correctly assess eligibility and carry out the informed consent process with participants.
• Measures projects progression toward successful completion of project goals; plans and ensures all corrective action and implementation.
• Maintains fiscal oversight; prepares budget modification requests to sponsor as needed; reconciles study budget accounts with business manager.
• Oversees proper project closure including finalizing all qualitative and quantitative data, and handing off any project deliverables such as study created decision aids, educational materials, and result summaries to the sponsor, stakeholders, and external partners.
• Coordinates the design and development of all databases that will ensure the accurate tracking of all individuals approached for studies and the safety and security of all data.
• Determines the activities, sequence and time allotted for each activity, and the resources required to achieve the projects' goals. Develops project plans including risk management plans; continuously assesses and updates the plans throughout the projects life cycle.
• Works with project teams to develop all required material including but not limited to advertising, recruitment brochures and letters, surveys, and educational materials for research participants and stakeholders.
• Coordinates activities of the project team including staff, operations support, consultants, vendors, patient, and community advisory boards, and co-investigators; fosters accountability and ensures that all project team members feel supported in their roles. Develops schedules for project staff.
• Assists in developing, writing, and submitting research proposals.
• Coordinates meetings and compiles proposal documents. Writes sections of the proposal especially the methods and human subjects sections. Prepares the proposal budget and justification in conjunction with other stakeholders.
• Responsible for accurate preparation and timely submission of all regulatory documents.
• Maintains current knowledge of regulatory affairs and/or issues; maintains a high level of expertise through familiarity of clinical literature and attending continuing education classes.

Bachelor's degree in a science or health related field.

5 years of clinical research experience.

Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire.

• Proficient written and verbal communication skills.
• Maintains a high degree of professionalism.
• Demonstrates time management and priority setting skills.
• Demonstrates a high commitment to quality.
• Possesses flexibility to work in a fast paced, dynamic environment.
• Seeks to acquire knowledge in area of specialty.
• Highly thorough and dependable.
• Demonstrates a high level of accuracy, even under pressure.
• Possesses a high degree of initiative.
• Ability to influence internal and/or external constituents.

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.

$62,000 - $67,000 per year based on experience and internal equity within the department.

Indianapolis, Indiana

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life,…