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Research Assistant II - Clinical Research Unit

Boston Medical Center

Boston, MA

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JOB DETAILS
SKILLS
Advertising, Case Report Form (CRF), Clinical Information Systems, Clinical Research, Clinical Trial, Clinical Trial Management, Communication Skills, Customer Support/Service, Data Analysis, Data Collection, Data Management, Data Quality, Detail Oriented, English Language, GCP (Good Clinical Practices), Government Regulations, Healthcare Providers, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Information Technology/Systems Audit, Informed Consent, Interpersonal Skills, Interviewing Skills, Maintain Compliance, Medical Records, Medical Treatment, Microsoft Access Database, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Multilingual, Organizational Skills, Outpatient Care, Patient Care, Presentation/Verbal Skills, Process Development, Program Evaluation, Quality Control, Regulations, Regulatory Compliance, Standard Operating Procedures (SOP), Statistical Analysis System (SAS), Systems Maintenance, Time Management, Training Tools, Web Browsers, Writing Skills
LOCATION
Boston, MA
POSTED
30+ days ago
POSITION SUMMARY:

Under the supervision of the Principal Investigator (PI), the Senior Research Assistant will be responsible for coordinating all aspects of a research study or clinical trial and assuring they are carried out using established principles, protocols and techniques. Duties include subject recruitment and enrollment, obtaining informed consent, data collection, data analysis, completion of case report forms, enrollment reports, review and submission of IRB protocols, and participation in audits and monitoring visits. Will serve as primary contact between PI, central departments, and external contacts, including project sites, regulatory agencies and sponsors. Assists PI in the development of study design and methods, teaching tools, enrollment guides, patient handbooks, and case reports. Possibility of advancement to a supervisory role. Requires a two-year commitment.

The Research Assistant II will coordinate and implement subject recruitment, enrollment, follow-up, data collection, and study conduct. Responsibilities include identifying and screening research subjects, recruiting and maintaining follow-up of research subjects, tracking absent (lost to follow) subjects, explaining and acquiring signatures of subjects for informed consent documents, data collection, database entry (including, but not limited to, data entry, transcription of qualitative questionnaires and coding of qualitative data), and participation in study meetings and performing other administrative tasks in support of the clinical studies.

Position: Research Assistant II

Department: Clinical Research Unit

Schedule: Full Time

ESSENTIAL RESPONSIBILITIES / DUTIES:
  • Under the supervision of the PI(s), monitors study's guidelines and policies with the purpose of ensuring compliance with all government regulations, as well as maintaining alignment with the organization's mission.
  • Coordinates all aspects of a research study from initiation to close-out.
  • Recruits subjects to participate in studies by using approved methodologies, such as, reaching out to healthcare providers for referrals, approaching potential subjects in the clinic, using approved advertisements, etc.
  • Conducts the screening and/or enrollment of study participants, in both inpatient and outpatient settings, including explaining research procedures, and obtaining informed consent of subjects; as well as interviewing human research subjects for research studies.
  • Works with the PI to evaluate program outcomes and to ensure culturally appropriate continuum of services for clients.
  • Monitors the timelines for each assigned research project and ensuring that the projects proceed according to schedule.
  • Oversees the collection of data and the tracking and recruitment of study subjects.
  • Maintains data management systems ensuring timely and accurate data collection. Systems may include REDCap, InForm, iMedidata etc. Audits systems for quality control and review of collected data.
  • Assists in reporting to funders, the Institutional Review Boards, and study sites. This may include IRB modifications and applications, and study site required applications and modifications.
  • Serve as primary contact for PIs, internal Boston Medical Center departments and external contacts including project sites, regulatory agencies and project sponsors.
  • Maintains confidentiality with regard to patient information and other sensitive information. Adheres to Good Clinical Practice (GCP) and follows all Standard Operating Procedures.
  • Identifies process deficiencies and recommend and implement new methods to create efficiencies in clinical trial management.
  • Maintains competencies required by the department and applicable agencies, including certification to work with Human Subjects.
  • May assist with IRB submissions, reports and amendments, as needed.
  • Performs other duties, as assigned or as necessary.

JOB REQUIREMENTS

EDUCATION:
  • Bachelors degree required and at least 1-2 years of clinical research experience
  • Masters degree preferred

KNOWLEDGE AND SKILLS:
  • Outstanding interpersonal skills to interact with patients, physicians, staff, students, and collaborators and to represent the research team on an ongoing basis.
  • Cultural sensitivity and comfort with a wide range of social, racial and ethnic populations.
  • Excellent English communication skills, both oral and written.
  • Bilingual or multi-lingual skills (beyond that of English) appropriate to the patient population served is desirable
  • Excellent organizational skills, including strong attention to detail and ability to manage time effectively
  • Ability to work autonomously and collaboratively as a team.
  • Proficiency with Microsoft Office applications (i.e., Word, Excel, Access, PowerPoint, Outlook) and web browsers. Experience with clinical platforms, clinical research systems, and statistical analysis tools a plus.
  • Must be able to maintain strict confidentiality of all personal/health sensitive information.
  • Knowledge of ICH-GCP guidelines

Req id: 29622

About the Company

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Boston Medical Center