Clinical Research Coordinator I (Eye Research)
The Clinical Research Coordinator I performs activities related to coordination and implementation of research protocols within the Beetham Eye Institute and Eye Research Section (both clinical trial and non-trial research).
Responsible for ensuring quality adherence to protocol-specific and general regulatory requirements for both translational research and clinical trial efforts. Assists in the development and maintenance of recordkeeping systems and sample repositories as well as procedures to rigorously track, prepare and store patient data and samples for research purposes. Performs a variety of complicated tasks, manages sophisticated equipment data transfers and has a wide degree of creativity and latitude. Recruits study participants and coordinates participant visits. Assists in administration of studies within BEI and may serve as an administrative liaison for multicenter studies that are led by the BEI team.
Individual is expected to work constructively within the BEI research team and cooperate well with the clinical staff and faculty of the BEI.
- Plans and coordinates the initiation of research study protocols
- Coordinates with lab (local or central) and pharmacy as needed for
- Specimen processing
- Specimen aliquotting
- Specimen labeling
- Specimen shipping
- Maintains accurate and comprehensive records regarding clinical specimens and organizes and tracks the Eye Research sample repository
- Organize and manages IRB submission or assists in this process for new and ongoing clinical or translational studies
- Assists with patient recruitment/enrollment for clinical research studies to meet desired quotas for participants that fulfill existing eligibility criteria, obtains informed consent from patients for participation.
- Schedules clinical research-related patient appointments. Takes appropriate corrective action with patients not adhering to protocol timelines.
- Ensures appropriate diagnostic testing has been performed per protocols, and ensures laboratory reports are reviewed by appropriate provider.
- Creates and maintains organized source documents in a timely and accurate manner including (but not necessarily limited to) study enrollment logs, case report forms, and Committee of Human Studies (CHS) applications and progress reports and responds promptly and accurately to Protocol Queries.
- Reports serious adverse events (SAE) in a timely fashion
- Completes assigned reports including periodic and ad hoc reports, as required by the investigator, administrators, funding agencies, and/or regulatory bodies.
- Prepares and/or attend audits of any BEI clinical trials
- Participates in patient education initiatives regarding diabetic retinopathy and clinical trial research opportunities at the BEI/JDC, discusses clinical trial offerings with patients scheduled for regular clinic visits to maximize interest and patient enrollment
- Monitors/orders necessary supplies.
- Assists the principal investigator with various administrative tasks associated with the day-to-day operations of research studies and projects
- Works to ensure correct and timely billing of study procedures and examinations
- Serves as liaison for Dana Farber Cancer Institute, Beth Israel Deaconess Hospital and other study collaborators for patient scheduling, visit flow and study invoicing.
- Other duties as assigned.
- Bachelor’s degree in science area, health sciences, public health or related field.
- Minimum 1 year experience conducting clinical research studies or in a medical research setting.
- Previous experience involving interaction with patients or clients
- Previous experience in an ophthalmic clinical or research setting is preferred but not required
- Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professions) is preferred
- Proficient knowledge of Microsoft Office Suite
- Knowledge of electronic medical records preferred
- Understanding of ICH/GCP guidelines for human research
- Understanding of Code of Federal Regulations for Human Subject
- Strong interpersonal, organizational, and communication skills (communicate clearly and effectively via verbal and written instruction)
- Ability to speak on a one-to-one basis to engage and recruit patients, and to explain study protocols and processes.
- Attention to detail and ability to concentrate on multiple tasks
- Detail oriented, with the ability to prioritize responsibilities – through completion
- Ability to work both independently and collaboratively with other members of the lab, professional staff, and external contacts
- Demonstrate ability to follow policies and procedures mandated by Joslin Diabetes Center, HIPAA, OSHA, and the DPH.
Joslin is an Equal Opportunity Employer of Minority/Female/Individuals with Disabilities/Protected Veterans. Joslin values diversity and inclusion, and we encourage diversity applicants.
Joslin Diabetes Center is an Equal Opportunity Employer and it is the policy of Joslin to prohibit discrimination of any type and to afford equal employment opportunities to employees, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, marital/parental status, disability status, protected veteran status or any other status protected by law. We comply with the laws and regulations set forth by the U.S. Department of Labor: EEO is the Law and EEO is the Law Supplement.