Clinical Research Assistant

🌟What We Offer

• 401(k) plan with company match
• Opportunities for professional development and career growth
• A mission-driven culture focused on advancing medicine and improving patient outcomes

Responsibilities:

• Study Preparation
• Prepare and maintain study documents, including source charts, study binders, regulatory binders, and laboratory kits.
• Schedule and confirm subject appointments, including ancillary visits such as diagnostic imaging and vendor-related services.
• Understand study protocols, inclusion/exclusion criteria, and regulatory requirements, ensuring compliance with FDA, Sponsor, and Good Clinical Practice (GCP) guidelines.
• Assist in participant recruitment by prescreening electronic medical records, following up on referrals, and coordinating outreach efforts.
• Participant Care and Interaction
• Provide subject care, including explaining study procedures, answering questions, and monitoring diary compliance.
• Conduct study procedures, such as collecting vital signs, performing ECGs, and completing study questionnaires.
• Perform follow-up and reminder calls to ensure subject adherence to visits and study protocols.
• Assist with participant stipend tracking and processing.
• Laboratory and Specimen Handling
• Perform blood draws (phlebotomy) and process biological samples, including shipping per study requirements.
• Maintain laboratory equipment, supplies, and temperature control systems, ensuring compliance with study protocols.
• Generate and file weekly temperature reports for laboratory systems
• Data Entry and Management
• Enter and verify study data in Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and other databases.
• Address system-generated queries and perform quality control checks to ensure data accuracy and completeness.
• Assist with case report forms (CRFs) and source document completion, including query resolution under study coordinator guidance.
• Administrative and General Support
• Maintain and organize participant charts, Investigator Site Files, and other regulatory documents.
• Support clinical research coordinators (CRCs) by filing, scanning, and faxing required documents.
• Clean, stock, and maintain exam rooms and department supplies to ensure readiness for participant visits.
• Participate in investigator meetings, study teleconferences, and trainings.
• Assist with onsite or remote clinical research monitor visits.

Requirements:

• Bachelor’s degree preferred or equivalent experience;
• 1+ year of experience within a clinical research or healthcare environment.
• Medical Knowledge: Familiarity with medical terminology, lab procedures, and research protocols preferred.
• Attention to Detail: Ability to collect, compile, and analyze data accurately.
• Communication & Customer Service: Strong interpersonal, verbal, and written communication skills.
• Technical Skills: Proficiency in Microsoft Office and Electronic Data Capture (EDC) systems.
• Adaptability & Problem-Solving: Ability to prioritize tasks, meet deadlines, and work in a fast-paced environment.
• Collaboration & Independence: Comfortable working both independently and within a team.
• Compliance & Confidentiality: Understanding of HIPAA, FDA, GCP, and ICH guidelines (preferred).
• Research & Lab Skills: Basic computer literacy, with lab skills (e.g., blood draws, specimen processing) preferred.
• Certifications (Preferred): BLS/CPR, CNA, CMA, or similar certification.
• Headlands Research will never ask a candidate for personal identifiable information (date of birth, social security number, driver’s license information, etc) via email or messenger tools, or for a financial deposit of any kind.
• Headlands Research is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability status, genetic information, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
• Need Assistance?
• Headlands Research is committed to providing access and reasonable accommodation in its employment for individuals with disabilities. To request disability accommodation in the application process, contact [email protected] for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
• Proficiency in Microsoft Office and Electronic Data Capture (EDC) systems.

Need Assistance?

Preferred Qualifications

• Bachelor’s degree preferred or equivalent experience;
• Medical Knowledge: Familiarity with medical terminology, lab procedures, and research protocols preferred.
• Compliance & Confidentiality: Understanding of HIPAA, FDA, GCP, and ICH guidelines (preferred).
• Research & Lab Skills: Basic computer literacy, with lab skills (e.g., blood draws, specimen processing) preferred.
• Certifications (Preferred): BLS/CPR, CNA, CMA, or similar certification.