Essential duties and responsibilities:
- Obtaining informed consent per ICH/GCP and site SOPs.
- Interviewing and collecting data from study participants.
- Scheduling subject visits according to clinic protocol and study protocol.
- Obtaining subject vital statistics (including height, weight, BMI, pulse, respiratory rate, blood pressure, etc.).
- Dispensing/collecting study medicationper Protocoland providing accurate Investigational Product accountability.
- Collecting subject laboratory specimens according to protocol, processing, and shipping per IATA guidelines with IATA certification.
- Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned and required by Sponsor.
- Maintaining a thorough understanding of all data collection instruments.
- Collecting of data accurately and maintains strict adherence to Protocols.
- Ensuring IP is maintained under temperature control per protocol.
- Maintains as Lead Coordinator on 4 Studies
- Performs Backup Coordinator Duties as designated.
- Performs Unmasked Duties as designated.
- Other duties as assigned.
This position requires flexibility, excellent organizational/communication skills and attention to detail.Ability to prioritize and organize a high volume workload with changing priorities.
- Bachelor’s degree (BS) and a minimum of 2 year recent experience as a research coordinator or a minimum of 4 years’ experience as a Lead Coordinator.
- Ophthalmology & Retina experience preferred.
Combined Skills and Attributes:
- Computer literate and experience using EMR,MS Office suite, Web Browsing, Email, Spreadsheets.
- Ability to construct(develop)source documents.
- Adaptable and able to learn quickly.
- Meticulous and detail oriented.
- Able to follow direction with minimal supervision.
- Respond quickly to Manager’s requests.
- Excellent written and verbal communication skills.
- Excellent customer service skills.
- Takes initiative and team player.
- Organized, excellent time management skills.
- Must be able to multitask.