Clinical Research Coordinator I

Found in: Resume Library US A2 - 6 days ago

Boston Massachusetts, United States Joslin Diabetes Center Full time
Overview:
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).

 

The Clinical Research Coordinator I is responsible for ensuring quality adherence to protocol-specific and general regulatory requirements for translational research and clinical study efforts.  Assists in the development and maintenance of recordkeeping systems as well as procedures to rigorously track, prepare and store patient data for research purposes.  Performs a variety of complicated tasks, manages sophisticated equipment data transfers and has a wide degree of creativity and latitude.  Assists in administration of studies within BEI and may serve as an administrative liaison for multicenter industry and non-industry studies for 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.

 

As a health care organization, we have the responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. We require that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment.

Responsibilities:
Plans and coordinates the initiation of research study protocols along with the other members of the BEI clinical research team.

Obtains and maintains certification for clinical research protocol visual acuity and refraction as well as certifications for visual function testing and retinal imaging as needed for current BEI studies.

Performs portions of the ophthalmic examination, including refraction, visual acuity, and intraocular pressure testing for clinical study patients.

Coordinates with lab (local or central) and pharmacy as needed forSpecimen processing

Specimen aliquotting

Specimen labeling

Specimen shipping

Maintains accurate and comprehensive records regarding clinical specimens and organizes and tracks the Eye Research sample repository.

Creates research applications and informed consent documents for industry-sponsored clinical studies and BEI clinical studies for IRB review/approval.

Maintains accurate and comprehensive clinical trial records.

Organizes and manages IRB submissions for new and ongoing clinical or translational studies.

Organizes and manages BEI staff trial certifications.

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. Responds promptly and accurately to Protocol Queries.

Reports serious adverse events (SAE) in a timely fashion.

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.

Completes assigned reports including periodic and ad hoc reports, as required by the investigator, administrators, funding agencies, and/or regulatory bodies.

Prepares for and/or attend audits of any BEI clinical trials.

Assists the principal investigator with various administrative tasks associated with the day-to-day operations of research studies and projects.

Serves as liaison for Dana Farber Cancer Institute, Beth Israel Deaconess Hospital and other study collaborators.

Other duties as assigned.

Qualifications:
• 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.

 

 

 

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