GENERAL SUMMARY/ OVERVIEW STATEMENT:


The Clinical Research Coordinator is responsible for working closely with Dr. Balaj in a liquid biopsy research projects at the MGH. Under general direction of the Principal Investigator, this individual is responsible and accountable for playing a major role in assisting in the implementation of research protocols using scientific methods, including working with physicians, clinical nurses and patients to identify and recruit eligible patients, obtaining all necessary approvals and informed consent forms, screening and enrolling patients into the study, ensuring blood, urine, CSF, tissue and saliva are collected on time, and acting as a liaison between the patient and other members of the team regarding the research protocol. The Coordinator is responsible for database development and data entry of patient data for the study, and is responsible for consistently examining medical records to ensure all logged clinical information is up to date. The Coordinator works closely with personnel at the MGH site, ensuring that biospecimens are handled and received appropriately and biomarker correlative studies are performed in accordance with study protocols. He/She logs in all applicable data elements as requested and coordinates information and supply transfer as necessary to complete study elements at multiple sites. He/She summarizes data and information for review and analysis by the investigators and project team, participates in regular lab meetings, and has the opportunity to assist with data analysis and production of presentations and manuscripts.


PRINCIPAL DUTIES AND RESPONSIBILITIES:


Coordinates and implements research study according to the study protocol. Demonstrates understanding and knowledge of designated study protocols and methods of implementation.


Organizes, establishes and maintains the research database and uses the database to extract information for reports, papers and feedback to the study team. When called upon by a member of the research team, works to establish specimen cohorts that meet specific criteria regarding number of patients, diagnoses, diagnostic molecular markers, types of biospecimens available etc.


Collects, compiles, tabulates biobank data. Ensures that data is entered into the database accurately and in a timely fashion. Works to ensure that appropriate control systems are in place to monitor the progress of data acquisition and to define new approaches to data management. Periodically assesses quality and completeness of database and patients' files. Maintains all required records including documentation of all consents in both an electronic and physical manner, and information needed for the Institutional Review Board, granting agencies, and other regulatory and/or funding bodies. Serves as a resource in providing statistical information from the database.


Assists in writing research publications or funding applications. Performs independent literature searches and selects references for final publication. Prepares data and graphics. Assists in presenting study findings to interested groups both inside and outside of the hospital.


Performs administrative duties such as protocol design, data analysis, quality assurance, grant preparation, documentation for Human Studies approval, study progress reports, and manuscript preparation.


Works with physicians, clinical nurses and patients to identify and screen appropriate candidates for protocols and evaluates criteria for inclusion/exclusion per study protocol. Obtains and files all necessary approvals, patient written informed consent, and demographic information required for patient enrollment.


Contacts patients and/or families via in person, written and telephone communications for the purpose of explaining the nature of the study and setting up visits and interviews. Arranges and coordinates scheduling of initial assessment and subsequent assessments, if necessary, as outlined in study protocol.


Schedules blood sample collection at the appropriate times according to the protocol and sets up blood draw kits. Arranges transport of samples for processing. Processes and stores blood collections according to the protocol. Works closely with the other clinical sites ensuring that blood specimens are handled and received per protocol by all sites. Schedules longitudinal blood draws for patients enrolled in the study and who are already scheduled to come back to the hospital for clinically indicated reasons.


Maintains close, working relationships with various members of the hospital who assist in the collection of patient biospecimens, namely anesthesiologists, clinical nurses, surgeons, pathologists, administrators etc.,


Collects, analyzes and assures the quality of pertinent patient documentation according to established guidelines. Maintains confidential patient files including all correspondence, information, raw data and follow-up status of all study patients. Documents and maintains specific protocol information and communications according to the established guidelines of the unit.


Monitors study progress by gathering information and reviewing materials, visiting patients in the study, discussing problems and exchanging information with clinical nurses and other care providers and study personnel.


Assesses learning needs and educates patients and family as appropriate regarding protocol management and participation in research project. Ensures that patients and/or their family members have comprehensive understanding of what participation in the research study entails.


Organizes project team meetings and prepares the agenda under direction of the principal investigator.


Assesses patient participation on a continuous basis in light of ethical considerations. Acts as liaison between patient and other members of the team regarding the research protocol.


Responsible for developing and maintaining a web page for study information in conjunction with the Principle Investigator, Administrative Director, Marketing and the Research Management Office.


Designing/implementing advertisements when appropriate for research study recruitment.


Establishes effective working relationships with the project team.



Qualifications

SKILLS/ABILITIES/COMPETENCIES REQUIRED:


• Exceptional computer skills (including operating systems, word processing, database, electronic mail, internet, and spreadsheets) required.


• Good command of English language, including medical and scientific terminology.


• Exceptional organizational skills and the flexibility to handle multiple tasks and deadline pressures.


• Effective analytical skills.


• Excellent interpersonal/ communication skills.


• Ability to maintain composure and compassion when speaking with patients and their family members about research participation


EDUCATION:


• Bachelor's degree required in a science or healthcare related field.


EXPERIENCE:


Job experience in health care setting and handling biological specimens preferred.


FISCAL RESPONSIBILITY


No direct fiscal responsibilities: however, is responsible for prudent fiscal management of program resources (e.g. supplies, etc.). Reviews study funds each month to assess proper reimbursement for submitted paperwork. Works with senior grant administrator for specific budget issues.


WORKING CONDITIONS:


Duties will be performed in a hospital inpatient, clinic, laboratory, and office setting.