Clinical Research Coordinator II, Infectious Diseases

Position: Clinical Research Coordinator II

Department: Research - Infectious Diseases

Location: Boston, MA

Schedule: 40 hours per week

POSITION SUMMARY:

The Clinical Research Coordinator II is responsible for on- and off-site study implementation and data management of clinical research studies on tuberculosis (TB) at both domestic and international sites. The CRC II will be responsible for development and oversight of study documentation (i.e., protocols, data management and clinical quality management plans, standard operating procedures, informed consent forms, logs, etc.) and maintaining ethics compliance. Interested candidates should have strong data analysis and computing programming skills and be able to manipulate, transform, analyze and summarize large data sets.

Organizes, manages, conducts and directs health services research projects, with primary responsibility for handling all the day-to-day administrative and management issues related to ongoing research studies. Functions include the recruitment of subjects, subject interviews, managing research databases for regular reporting on enrollment, serving as study liaison with the IRB and other participating study sites, serving as a nursing and investigational pharmacy liaison, and the collection of biological specimens. Assists with new grant proposal development, and preparation of research reports and presentations.

JOB RESPONSIBILITIES

Protocol and study document development

• Supports development of clinical/scientific study protocols, informed consent forms (ICFs), manuals of procedure (MOPs), and standard operating procedures (SOPs) for domestic and international studies.

• Develops case report forms (CRFs) and other data collection tools and leads design and validation of electronic data capture (EDC) systems and databases (e.g., REDCap).

• Supports development of data management plans (DMPs) and clinical quality management plans (CQMPs) for studies, including plans for regular quality control/assurance (QA/QC) on study data and protocol implementation.

• Performs quality assurance/control (QA/QC) per DMPs and CQMPs for each protocol.  Coordinate QA/QC with on-site staff and investigators.  

• Develops training materials on study protocols, research and clinical SOPs, and data collection procedures and supports training of study teams [e.g., research assistants (RAs), research nurses, field workers.  

Study Implementation

• Maintains ethics and regulatory compliance, including initial international and domestic institutional review board (IRB) and ethics committee (ECs) submissions, amendments, reportable events, and annual reporting. Maintains regulatory binders and study master files. 

• Under guidance of Investigator and Manager, oversees the launch of new domestic and international studies. Ensures protocol adherence and smooth study implementation for ongoing studies. Serves as the conduit between various study sites, including laboratory partners. 

• Supports study teams through regular meetings and ongoing training and support on protocol implementation.

• Conducts domestic and international site monitoring visits to meet with stakeholders and perform audits on study protocol adherence and implementation. 

• Maintains EDCs and data dictionaries. Ensures data integrity and protocol adherence by conducting routine on-site and remote QA/QC procedures per DMPs and CQMPs.

• Reports to investigators on study progress and protocol milestones. Generates routine progress reports and aids in preparing annual reports to donors and ethics.

• Works with investigators and statisticians in creating databases/datasets for analyses and performs descriptive analyses using statistical package (e.g., R).

• Works closely with Manager to navigate deviations from protocol, displays forethought in identifying potential crises and devises appropriate contingency plans

Other duties

• Aids in preparation of abstracts, posters, and manuscripts for scientific meetings and journals.

• Schedules and leads regular study team meetings, sets agendas, and records minutes for distribution. 

• Prioritizes work to ensure appropriate and timely preparation for meetings and meets deliverable deadlines.

• Performs other duties as needed or as assigned to ensure smooth operations and responsiveness of projects and team.

• Spends ~5-10% time at international study sites

JOB REQUIREMENTS

EDUCATION/EXPERIENCE:

CRC II: Experien