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 act as a primary coordinator on research trials, while also being a primary resource for colleagues and staff. Including training and orientating as appropriate. The research trials may include treatment trials, biomarker trials, imaging trials, and other research. The incumbent will lead regular meetings of coordinators to help problem solve issues or escalate as needed, review work of trainees, help coordinate activities, and obtain information to aid development of QA/QC systems (which will be done with Associate Site Director). Often responsible for reporting and discussing studies during investigators' meetings. Able to troubleshoot acute needs for research at NCRI, within scope of a non-licensed clinical research coordinator. Will also help to coordinate patient flow in Amyotrophic Lateral Sclerosis (ALS) Clinic as indicated by healthcare providers.
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 research data, patient files, regulatory binders, and study databases.
Reviews work of trainees.
Develops and implements recruitment strategies for patients in clinical trials.
Verifies accuracy of study forms and updates study forms per protocol.
Prepares data for analysis and data entry
May develop systems for QA/QC.
Assists with interviewing study subjects and administers/scores questionnaires.
Provides explanations of site-wide studies and in some cases obtains informed consent from subjects.
Performs study procedures such as phlebotomy, vital signs, and electrocardiogram.
Independently judges suitability of research subjects.
Acts as a study resource for patient and family.
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.
Recommends changes in protocols.
Can act as a liaison with Human Resources.
Performs and designs statistical analysis.
Assists professional staff with patient treatment according to study guidelines. For example, arranges specific blood draws; performs phlebotomy; processes fluids; records medical histories; provides patient education and conducts preps for specific procedures.
Also advises physicians on required tests, timing of tests, procedures to be followed in response to suspicious test result, per protocol. Assures physicians 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.
Acquires detailed knowledge of assigned studies so as to serve as the in-house expert for the assigned study and to triage calls from the professional and support staff.
Acts as a resource and liaison to support staff, Financial Affairs, IRB, Harvard Catalyst CRC, Pharmacy, Pathology, and study monitors of sponsor.
Interacts internally with other hospital departments such as Dieticians and Environmental Services as needed, and externally with personnel of regulatory agencies.
Responsible for quality control.
Accepts responsibilities for special projects as requested.
Other job related duties as required.
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 work at different MGH or Partners sites including Main Campus, Charles River Plaza, and Charlestown Navy Yard.
High level time management and organization skills.
Administrative skills to meet regulatory requirements.
Knowledge of current and developing clinical research trends.
Ability to meet the requirements of varying funding sources.
Sound interpersonal skills and the ability to supervise others.
Ability to work independently and as a team member
Displays initiative to introduce innovations to research study.
Ability to identify problems and develop solutions.
Careful attention to details
Excellent verbal and written communication skills.
Excellent understanding of scope of practice.
Conduct appropriate decorum with direct contact with a terminal patient population
High level of computer literacy
Bachelor's degree required.
Minimum of 3-5 years of related experience required.
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.