Clinical Research Coordinator I (Eye Research)
Company: Joslin Diabetes Center
Posted on: January 27, 2023
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
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.
Plans and coordinates the initiation of research study protocols
along with the other members of the BEI clinical research team
Creates research applications and informed consent documents for
industry-sponsored clinical studies and BEI clinical studies for
Maintains accurate and comprehensive clinical trial records
Organize and manages IRB submissions for new and ongoing clinical
or translational studies
Organize 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.
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
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 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
Serves as liaison for Dana Farber Cancer Institute, Beth Israel
Deaconess Hospital and other study collaborators.
Also serves as BEI Medical Retina Fellowship Coordinator. This
includes organizing the application process, interviewing process,
and credentialing for incoming fellows.
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
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
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
Detail oriented, with the ability to prioritize responsibilities -
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
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.
Keywords: Joslin Diabetes Center, Boston , Clinical Research Coordinator I (Eye Research), Healthcare , Boston, Massachusetts
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