Medical Assistant- Research
About The Position
The Medical Assistant- Research is responsible for performing research studies under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non-RN) manages implementation and ongoing conduct of research studies, applying foundational knowledge of clinical research. The role primarily supports entry-level-complexity study designs, such as Phase 4 and observational or registry trials, and their related procedures. The position administratively and clinically manages an average of five clinical trials open to accrual annually and/or an active on-treatment patient volume of 2–10 annually. The employee is expected to understand the role, applicable regulations, and organizational and departmental policies and procedures, and to perform other assigned duties in compliance with those requirements.
Requirements
- High school education required.
- Prior research or related medical science experience.
- Critical-thinking skills, including problem solving, analysis, decision-making, planning, time management, and organization; attention to detail and ability to exercise independent judgment.
- Interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness; ability to handle sensitive and confidential material and emotionally charged matters.
- Good command of English and effective oral, written, and presentation communication skills; active listening and balanced feedback.
- Strong customer focus and ability to collaborate and build effective relationships with employees, physicians, and the community.
- Ability to manage time, competing priorities, stress, and professional development; self-motivated, able to work independently with limited supervision, and able to work remotely effectively as required.
- Ability to work effectively in a fast-paced, multi-site environment and manage competing demands from varied stakeholders and sites.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
- Ability to perform work Monday to Friday, 8:00 AM–5:00 PM.
Nice To Haves
- Some college.
- A second language.
- Prior experience with electronic medical records (EMR).
- Prior experience with clinical trial data entry systems (EDC).
- Prior experience with Clinical Trial Management Systems (CTMS).
Responsibilities
- Coordinate care for patients enrolled in clinical research protocols in accordance with GCP and ICH/FDA guidelines and requirements.
- Identify and explain protocol elements and perform study tasks under direct supervision.
- Conduct protocol feasibility assessments and complete feasibility and site-assessment questionnaires.
- Apply inclusion and exclusion criteria and follow subject identification, prescreening, screening, and rescreening processes.
- Understand informed-consent form requirements and the essential elements of the informed-consent process.
- Review diagnostic tests and related documentation required by protocols.
- Follow processes for capturing, assessing, determining causal relationships, documenting, reporting, and following up on adverse events under direct supervision and investigator oversight.
- Ensure proper storage, dispensing, handling, and destruction of investigational products, and follow procedures for compromised products.
- Follow IRB/IEC review, approval, and reporting requirements; maintain site credentials and ensure current GCP documentation and licenses are on file.
- Report safety-related subject discontinuations and safety concerns, including AEs, SAEs, and AEs of Interest, to sponsors and the IRB/IEC.
- Collect, record, and report accurate data in accordance with FDA guidelines, and review data against patients’ medical records for completeness and accuracy under direct supervision.
- Protect the scientific integrity of data and the rights, safety, and well-being of clinical-trial participants.
- Prepare documents for monitoring visits under direct supervision, review monitoring follow-up reports or letters, and complete requested activities.
- Escalate protocol non-compliance issues to the study PI and research department leadership.
- Identify elements of study budgets as they relate to protocol execution.
- Perform other duties and projects as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
