Description

The Clinical Research Coordinator (CRC) is the primary point of contact for the study patient and sponsor representatives. The CRC works closely with the Principal Investigator and Sub-Investigator to ensure the safety and well-being of the study patient is protected. CRCs are expected to maintain all documents, processes, and supplies for all assigned duties according to protocol.

Essential functions:

1. Study recruiting activity, including pre-screening, screening, and recruitment of patients. Obtains informed consent per ICH/GCP and site SOPs. Interviews and collects data from study patients.
2. Creates and completes source documentation and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned.
3. Maintains a thorough understanding of all data collection instruments and collects data accurately and according to protocol. Performs basic data gathering, EDC transcription, and manipulation of source documents. Maintains regulatory binders (ISF) with applicable documents and communicates effectively with study monitors (CRAs) during site visits and audits.
4. Coordinates study visits and performs procedures such as AE collection, ConMeds, and eye pressure assessment. Schedules subject visits as needed and obtains vitals (height, weight, pulse, respiratory rate, blood pressure, etc.) and ECGs.
5. Dispenses and collects study medication and provides accurate Investigational Product (IP) accountability. Reports temperature excursions in a timely manner.
6. Collects and processes laboratory specimens for study participants according to protocol.

Other responsibilities: Duties assigned by the Clinical Research Supervisor/Manager or Director of Operations.

Requirements

Skills Required:

• Computer literate and experience using EHR, MS Office suite, web browsing, email, and spreadsheets. Adaptable and able to learn quickly. Meticulous and detail oriented. Able to follow directions with minimal supervision. Excellent written and verbal communication skills. Excellent customer service skills. Takes initiative, able to see a task that needs to be completed and completes it. Must be able to multitask and able to handle a high volume of patients. Open to work a flexible work schedule.

Experience required:

• 3-5 years as a clinical research coordinator.

Experience preferred:

• Additional past medical office experience. Preferred knowledge of the design ad conduct of clinical studies. Phlebotomy certification and experience preferred. Ophthalmology clinical research experience preferred.

Education required or equivalent:

• Bachelor's degree preferred.

Physical standards, including lifting and pushing requirements:

• Must be able to remain in a stationary position for 50% of scheduled shifts or more, be able to frequently move about the office to direct patients, access office supplies and equipment, and be able to lift up to 50 pounds. Must be able to communicate with patients to convey necessary medical and financial information and document accurately in EMR and practice management system.

Travel requirements:

• Study-related travel, including travel to clinic locations as needed and sponsor-related travel (investigator meetings, training, etc.).

Equipment:

• This position requires the use of telephone and office equipment such as computers, copier, fax machine, and scanner. Requires use of Microsoft Office products and occasional use of medical equipment such as exam chairs, imaging equipment, pharmaceutical refrigerators, and diagnostic testing equipment.

Unique conditions of the position:

• OSHA Classification Category I. Job duties include exposure to blood, bodily fluids, or tissues. 2-year commitment preferred.