The Study Coordinators responsibilities may be associated with one or more clinical research project(s). S/he works directly with patients with diabetes or other metabolic diseases and is responsible for coordinating assigned study/studies.
Responsibilities
Provides support on clinical research protocols. Recruits, schedules and interviews patients, both in person and via phone and email contact. Performs routine laboratory procedures (including measuring blood pressure, height and weight, and/or phlebotomy if certified) and other aspects of study protocol, and escorts patients to testing locations. Coordinates patient recruitment to ensure the enrollment goals are met for multiple grants and/or industry sponsored clinical trials. Facilitates patient visits by performing protocol specific tests and procedures.
Assists with developing, maintaining and completing study data collection forms and source documents. Maintains research patient records and regulatory binders. Performs data entry and supervises data entry performed by others for each project.
Serves as the primary contact for study collaborators and/or sponsors, facilitating sponsors' regulatory and initiation visits. Prepares for regulatory and initiation visits by monitoring safety reports, completing start up source documents, maintaining compliance documents, and assisting in protocol feasibility evaluation with principal investigator.
Organizes the storage, maintenance, and use of the study related materials.
Participates with colleagues in the processing, labeling, organization, storage and retrieval and storage of study biospecimens.
Coordinates with Laboratory Cores for sample analysis. Processes laboratory samples and deliver samples to local laboratory or mails to central laboratory.
Performs ad hoc statistical analysis for the Principal Investigator using statistical programs available at Joslin.
Participates in the preparation of scientific publications and presentations of study scientific data.
Assists in training new team members in all clinical research protocols, including how to properly process and store samples.
Monitors deadlines and prepares IRB applications, progress reports and informed consent forms. Monitors serious adverse events reports from study sponsors and prepares appropriate documentation for IRB under supervision of the Principal Investigator. Prepares documents for the Committee on Human Studies and completes case reports forms.
Performs general laboratory support, including ordering supplies and equipment for all studies, and performing literature searches.
Activities for the studies will be performed at Joslin Diabetes Center and the other centers as required.
Will closely work with the staff involved in the study in and outside of Joslin Diabetes Center and under the supervision of the PI.
Participates in research team meetings
Other duties as assigned.
Qualifications
Bachelor's degree in the Biological Sciences/Chemistry or related science is required. Master's degree preferred.
Minimum 1 year research experience involving human subjects
Strong working knowledge of and/or aptitude for Microsoft Office Suite
Fluent in written and spoken English (Additional Spanish is preferable)
Strong verbal and written communication skills.
Strong interpersonal: to interact with other employees, professional staff and/or external contacts.
Must be detail oriented, with the ability to prioritize responsibilities - through completion.
Ability to maintain patient confidentiality
Ability to work independently and with others in the lab.
Maintain confidentiality of all patient information
Flexible schedule as necessary to accommodate study patients and recruitment activities.
