Job Title: Research Assistant I
Job Summary
The Research Assistant I is responsible for performing clinical research procedures in accordance with study protocols while ensuring participant safety, protocol compliance, and high-quality patient care. This role supports the successful execution of clinical studies by completing protocol-specific procedures, maintaining accurate documentation, and providing an exceptional participant experience.
Essential Responsibilities
- Ensure the safety, well-being, and comfort of study participants throughout all study activities.
- Monitor participants for adverse events and promptly intervene, document, and report findings according to study protocols.
- Adhere to protocol-specific schedules and required study timelines.
- Perform clinical procedures as outlined in study protocols, including:
- Vital signs
- Electrocardiograms (ECGs/EKGs)
- Physiological measurements
- Meal distribution and participant monitoring
- Preparation of study supplies and equipment
- Perform technical procedures within the scope of training and certification, including:
- Venipuncture and blood collection
- Catheter insertion (if applicable)
- Medication administration (when authorized)
- Explain informed consent documents to study participants and ensure consent is obtained, understood, and properly documented prior to study participation.
- Maintain adequate inventory of study supplies and equipment to support daily clinical operations.
- Accurately document study activities in accordance with Good Clinical Practice (GCP), study protocols, and applicable regulatory requirements.
- Provide professional, compassionate, and high-quality customer service to study participants.
- Collaborate effectively with investigators, clinical staff, and study teams.
- Perform additional clinical and research-related duties as assigned.
Qualifications
Required
- High school diploma or equivalent required.
- One of the following certifications:
- Certified Medical Assistant (CMA)
- Registered Medical Assistant (RMA)
- Certified Phlebotomist
- Other comparable healthcare certification may be considered.
- Current CPR/BLS certification (or ability to obtain upon hire).
- Experience performing venipuncture, vital signs, and ECG/EKGs.
- Strong communication and interpersonal skills.
- Basic computer proficiency and experience with electronic documentation systems.
- Ability to work in a fast-paced clinical research environment while maintaining attention to detail.
Preferred
- Previous experience in clinical research or clinical trial operations.
- Experience with informed consent procedures.
- Knowledge of Good Clinical Practice (ICH-GCP) guidelines.
- Bilingual (English/Spanish) preferred.
- Experience using electronic medical records (EMR), electronic data capture (EDC), or clinical trial management systems (CTMS).
Physical Requirements
- Ability to stand and walk for extended periods.
- Ability to lift and move up to 25 pounds.
- Manual dexterity to perform clinical procedures.
- Ability to work flexible schedules, including early mornings, evenings, weekends, or holidays, based on study requirements.