The Department

Infectious Diseases

ClinicalResearchCoordinator,InfectiousDiseases

$43–60k Boston, Massachusetts, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Clinical Research Coordinator, Infectious Diseases at The Department. Skills: study implementation, data management, protocol development, ethics and regulatory compliance. on- and off-site study implementation. data management of clinical research studies”

What You'll Achieve.

meet project milestones; support investigators in dissemination of findings; regular reporting on enrollment; meet deliverable deadlines

Industry & Context.

Infectious Diseases
Problems you'll solve

displays forethought in identifying potential crises and devises appropriate contingency plans

Eligibility Requirements

Spends ~5-10% time at international study sites, Flexibility to take occasional evening and weekend on-call when PI is not available

What They're Looking For.

Must Have

Master's Degree, Minimum 3 years of clinical research, public health research experience or research working with high-risk patient populations, Excellent English communication skills (oral and written), Knowledge of MS Office applications, database systems, and Internet, Must be able to maintain strict confidentiality of all personal/health sensitive information

Nice to Have

Bachelor's degree may be considered for candidates with at least 5 years of research experience, Previous experience with grant writing, IRB submissions, data management, and database development, Experience using quantitative data analysis software helpful (e.g., SPSS, SAS, Minitab)

What You'll Do.

on- and off-site study implementation

data management of clinical research studies

development and oversight of study documentation

maintaining ethics compliance

analyze and summarize large data sets

recruitment of subjects

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

collection of biological specimens

Assists with new grant proposal development

preparation of research reports and presentations

Supports development of clinical/scientific study protocols

informed consent forms (ICFs)

manuals of procedure (MOPs)

and standard operating procedures (SOPs)

Develops case report forms (CRFs) and other data collection tools

leads design and validation of electronic data capture (EDC) systems and databases (e.g.

Supports development of data management plans (DMPs) and clinical quality management plans (CQMPs)

Performs quality assurance/control (QA/QC) per DMPs and CQMPs

Coordinate QA/QC with on-site staff and investigators

Develops training materials on study protocols

research and clinical SOPs

and data collection procedures

supports training of study teams

Maintains ethics and regulatory compliance

maintains regulatory binders and study master files

oversees the launch of new domestic and international studies

Ensures protocol adherence and smooth study implementation

Serves as the conduit between various study sites

including laboratory partners

Supports study teams through regular meetings and ongoing training and support

Conducts domestic and international site monitoring visits

Maintains EDCs and data dictionaries

Ensures data integrity and protocol adherence

Reports to investigators on study progress and protocol milestones

Generates routine progress reports and aids in preparing annual reports

Works with investigators and statisticians in creating databases/datasets for analyses

performs descriptive analyses using statistical package (e.g.

navigates deviations from protocol

identifying potential crises and devises appropriate contingency plans

Aids in preparation of abstracts

and manuscripts for scientific meetings and journals

Schedules and leads regular study team meetings

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

Performs other duties as needed or as assigned

How You'll Work.

Team & Collaboration

work directly with study field teams; Coordinate QA/QC with on-site staff and investigators; Serves as the conduit between various study sites, including laboratory partners; Supports study teams through regular meetings and ongoing training and support; Schedules and leads regular study team meetings

Communication Scope

Excellent English communication skills (oral and written)

Process & Methodology

Organizes, manages, conducts and directs health services research projects, handling all the day-to-day administrative and management issues related to ongoing research studies, Ensures protocol adherence and smooth study implementation for ongoing studies, Prioritizes work to ensure appropriate and timely preparation for meetings and meets deliverable deadlines

Full Job Description

**Position** : Clinical Research Coordinator, Infectious Diseases **Location** : Boston, MA **Schedule** : 40 hours per week **POSITION SUMMARY:** The Study Coordinator 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 Study Coordinator 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. The Study Coordinator will work directly with study field teams to meet project milestones and support investigators in dissemination of findings. 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 deve

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