Clinical Research Coordinator I

Job Summary

Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; and maintaining and updating data generated by the study.

Essential Functions

• Reviews proposals for compliance with sponsor and organizational guidelines; verifies that all sponsor requirements are met.
• Recruiting patients for clinical trials and conducting phone interviews.
• Verifies the accuracy of study forms and updates them per protocol.
• Prepares data for analysis and data entry.
• Documents patient visits and procedures.
• Assists with regulatory binders and QA/QC Procedures.
• Assists with interviewing study subjects.
• Assists with study regulator submissions.

Additional Job Details

Working as a part of the Site at the Neurological Clinical Research Institute (NCRI), and working in collaboration with the multidisciplinary team, the incumbent will be responsible for supporting all aspects of clinical research coordination for studies at the NCRI. The research trials may include treatment trials, biomarker trials, imaging trials, and other research. The incumbent will be responsible for generating reports and maintaining records related to the assigned research studies. The incumbent will also provide administrative support to the professional and support staff of the NCRI, which may include providing support in the Amyotrophic Lateral Sclerosis (ALS) Clinic.

Primary Responsibilities

• Coordinates all activities of subjects participating in individual research studies, including scheduling patients for research studies and collecting, organizing, and documenting patient data from each visit.
• Maintains records and databases.
• Assists with recruiting patients for clinical trials.
• Obtains patient study data from medical records, physicians, etc.
• Verifies the accuracy of study forms.
• Update study forms per protocol.
• Prepares data for analysis and data entry.
• Assists with regulatory binders and QA/QC procedures.
• Administers and scores questionnaires.
• Provides a basic explanation of the study and, in some cases, obtains informed consent from subjects.
• Performs study procedures such as phlebotomy, vital signs, and electrocardiogram.
• Draft consent forms.
• Corresponds with the Institutional Review Board (IRB) for approval of protocol, notification of adverse events, continuation of study, annual reporting of studies, and submission of amendments.
• Assists professional staff with patient treatment according to study guidelines.
• Knows their primary study thoroughly so that they are able to answer questions (from study staff and patients) accordingly, such as the timing of tests or the protocol required lab orders.
• Ensures investigators receive results of tests, as appropriate.
• Provides, creates, and maintains record-keeping systems: data collection forms, consent forms, side effect sheets, drug accountability and medication logs, initialization forms, and case report forms (CRFs).
• Data entry of information into study databases.
• Communicate with the study sponsor, including scheduling/conducting monitoring visits.
• Works cooperatively with the study sponsor to ensure that good clinical practices are being followed.
• Interacts internally with other hospital departments such as Dieticians, Harvard Catalyst CRC, Pharmacy, and Environmental Services as needed, and externally with personnel of regulatory agencies.
• Performs other administrative support duties as assigned.
• Accepts responsibilities for special projects as requested.
• Other job-related duties as required.

Skills/Abilities/Competencies Required

• Conduct appropriate decorum with direct contact with a terminal patient population.
• Ability to multitask.
• Careful attention to details.
• Good organizational skills.
• Ability to follow directions.
• Excellent verbal and written communication skills.
• Able to work with deadlines and in times of stressful environments.
• Computer literacy.
• Ability to interact well with others and work well, as a part of a team, with minimal supervision a must.

Working Conditions

Office work. May have a rotating 8 hour shift on Tuesdays between 7:30am and 6:30pm. May travel. Exposure to dry ice and -80 degree freezers. May have to lift up to 20lbs and apply force to resist patients/subjects in hand held dynamometry. May be exposed to bodily fluids, including blood, urine, and cerebral spinal fluid. May work at different MGH or Partners sites including Main Campus, Charles River Plaza, and Charlestown Navy Yard.