Research Assistant I
Research Assistant I
DM Clinical Research
Boston, MA
See who DM Clinical Research has hired for this role
TheResearch Assistantwill be responsible for assisting the clinical research staff in conducting clinical research trials.
Duties & Responsibilities
- Completing DMCR-required training, including GCP and IATA
- Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols
- Assisting in the collection and recording of patient data per Sponsor requirements via the respective EDC system
- Timely and accurately assist in collection, management, and shipment of subjects' samples, and/or specimens
- Completing Sponsor-required training prior to study-start, including, but not limited to
- Sponsor-provided and IRB-approved protocol
- All amendments
- Investigator Brochure
- Sponsor-specified EDC and/or IVRS
- This includes completing the above-mentioned training prior to any study-related procedures being conducted on that said protocol should the RA be added to a protocol post-study start
- Maintaining clear, concise, accurate, and legible records
- Being prepared for and available at all required company meetings and monitoring visits for their assigned protocols at their respective site(s)
- Utilizing the most recent version of the Protocol, Informed Consent, and Investigator Brochures at their respective site(s)
- Assisting in the compilation and organization of all regulatory and administrative binders for their assigned protocols at their respective site(s) upon initial receipt of and wherever applicable
- Assisting in the creation of source documents for their assigned protocols at their respective site(s)
- Conducting patient visits
- Assisting in reporting Adverse and Serious Adverse Events to the appropriate authorities per Sponsor
- Assisting in addressing and resolving issues from internal/external audits and monitoring letters for all assigned protocols at their respective site(s) in a timely manner
- Assists with all other aspects of the study and conducts as needed
- Any other matters as assigned by management
Education:
- High school diploma or equivalent required
- Prior experience in clinical research is not required but preferred
- Phlebotomist certificate preferred
- Medical Assistant Certification preferred
- Knowledge of medical terminology required
- Must be detail-oriented and demonstrate attention to detail
- Excellent customer service skills
- Excellent computer skills
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Seniority level
Entry level -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Internet Publishing
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