Clinical Research Coordinator II - Program in Substance Use & Addiction Services - (3281432)
GENERAL SUMMARY:
Under supervision of the Principal Investigator (PI), the Clinical Research Coordinator (CRC) will provide support for the ongoing research efforts of the Massachusetts General Hospital (MGH) Program in Substance Use & Addiction Services (PSAS). The projects and research efforts of PSAS include federal grants, clinical operations/implementation grants, and other evaluative/quality improvement research projects. The individual will be expected to work very independently, but with support and guidance from the PI and alongside a team of CRCs involved in the broad research efforts across PSAS and its various services and clinics. The CRC will be responsible for acquiring IRB approval for all studies under PSAS, as well as collecting, organizing, managing, and presenting data. The CRC plays a key role in the maintenance and collaborative research efforts for PSAS. Additional information on PSAS can be found here: https://www.massgeneral.org/substance-use-disorders-initiative.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The responsibilities included in this position are the following:
1. Work with providers to determine patients’ eligibility for research studies and actively recruit participants
2. Introduce studies to potential subjects and obtain consent from interested parties and verify subject inclusion/exclusion criteria
3. Conduct initial and follow-up assessments with subjects in person and virtually at pre-determined intervals using validated assessment tools and record responses in Redcap, SPARs, or other databases as needed
4. Maintain and track all subject data and monitor follow-up intervals
5. Maintain records and databases
6. Manage distribution of research incentives (such as gift cards) for participating subjects
7. Obtain patient study data from medical records, physicians, etc. and through chart review of clinical data
8. Verify accuracy of study forms and update study forms per protocol
9. Prepare data for analysis and data entry and help with data evaluation
10. Assist with formal data audits
11. Act as back-up CRC for CTN-0098A Exhit Entre Study
a. Complete all CTN required trainings, such as Human Subjects Protection and Good Clinical Practice, as well as study specific training (e.g., assessments, data entering and management procedures, and using the data management system), and MGH IRB and Research Management required training
b. Conduct verbal and written consent processes, prescreening forms, obtain HIPAA Waiver of Authorization, ROIs, and review medical records to assess inclusion/exclusion criteria for interested patients.
c. Conduct baseline and follow-up assessments at 34, 90, and 180-days post discharge from the hospital which will entail collection of self-report data, questionnaires, and interview questions.
d. Maintain log of individuals approached for study participation and utilize various recruitment and retention strategies, including utilizing the Addiction Consult Team and direct phone, text, and social media outreach.
e. Enter and maintain data responsibly and accurately using source documents, entering data into electronic case report forms in Advantage eClinical (the data acquisition and management system) and work closely with the centralized Data and Statistics Center
f. Distribute and track distribution of research incentives
12. Assist in QA monitoring for CTN-0098A Exhit Entre Study
a. Verify accuracy of study forms and update study forms per protocol
b. Audit source documentation, including informed consent forms, HIPAA forms, and medical release forms as specified by the protocol
c. Ensure that paper source documentation matches information entered into eClinical
d. Assist PI with preparation for periodic visits by NIDA-contracted monitors to examine and audit our conduct of appropriate study procedure and adherence to regulations
13. Assist with constructing IRB protocols for new studies and revising existing ones by updating IRB-approved documents and coordinating submission/resubmission, including monitoring deadlines for and completing continuing reviews of existing IRB protocols.
14. Track and manage study progress for the PI through the entire timeline of the research process from active study recruitment through participant follow up to ensure all projects are accomplished and deadlines are met on time
15. Present on study progress to research committee/project teams on regular intervals
16. Perform administrative support duties as required and other duties as assigned
QUALIFICATIONS/SKILLS/COMPETENCIES REQUIRED:
This position requires a high degree of independence, flexibility, and ability to work on multiple projects with competing priorities. The position requires strong communication skills and the ability to converse comfortably and respectfully with patients, caregivers, providers, and other clinical and administrative staff. This position requires the ability to work with diverse patient populations with empathy and understanding.
EDUCATION:
EXPERIENCE:
EEO Statement 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.
: MA-Boston-MGH 15 Parkman
:
MGH 15 Parkman
15 Parkman Avenue
Boston 02114
: Clinical
: Massachusetts General Hospital(MGH)
: Full-time
Standard Hours: 40
: Day Job
: Regular
Recruiting Department: MGH Psychiatry
: Mar 13, 2024
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