Clinical Research Coordinator
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GENERAL SUMMARY/ OVERVIEW STATEMENT:
Under supervision of the Associate Site Director of the Neurological Clinical Research Institute (NCRI), and working in collaboration with the multidisciplinary site 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.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Primary Responsibilities include but not limited to:
- Coordinates all activities of the subjects participating in the individual research studies such as scheduling patients for research study and collecting, organizing, and documenting the patient data from the visit.
- Maintains records and databases.
- Assists with recruiting patients for clinical trials.
- Obtains patient study data from medical records, physicians, etc.
- Verifies accuracy of study forms.
- Updates study forms per protocol.
- Prepares data for analysis and data entry
- Assists with regulatory binders and QA/QC procedures
- Administers and scores questionnaires.
- Provides basic explanation of study and in some cases obtains informed consent from subjects.
- Performs study procedures such as phlebotomy, vital signs, and electrocardiogram.
- Drafts 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. For example, arranges specific blood draws; performs phlebotomy; processes fluids; records medical histories; sets up room for study specific procedures.
- Knows their primary study thoroughly so that they are able to answer questions (from study staff and patients) accordingly such as timing of tests or protocol required lab orders.
- Assures 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 study sponsor including scheduling/conducting monitoring visits.
- Works cooperatively with study sponsor to ensure that good clinical practices are being followed.
- Interacts internally with other hospital departments such as Dieteticians, 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 organization skills
- Ability to follow directions
- Excellent verbal and written communication skills.
- Able to work with deadlines and at times stressful environment.
- Computer literacy
- Ability to interact well with others and work well, as a part of a team, with minimal supervision a must.
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable):
None
EDUCATION:
Bachelor's degree required.
EXPERIENCE:
Relevant course work or project work.
An understanding of federal regulations (i.e. FDA, CFR, etc.), IRB review process, informed consent, trial design, data monitoring as well as good writing and editing skills a plus.
Prior experience working in clinical research a plus.