Headlands Research
Location
Baltimore, Maryland
The role involves supporting clinical trial visits by performing phlebotomy, collecting patient vitals, and managing biological samples. Additionally, the assistant handles study documentation, data entry into EDC/CTMS systems, and general administrative support for research coordinators.
Candidates must have a bachelor's degree, a health-related college program, or a certification as a CNA, Medical Assistant, or Phlebotomist. Experience with ICH GCP guidelines and direct patient care is required, with phlebotomy training being heavily preferred.
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. What Makes You a Great Fit Strong attention to detail and ability to follow step-by-step procedures Ability to work efficiently in a fast-paced environment with changing priorities Strong communication skills and a professional, patient-focused demeanor Comfortable interacting with a diverse patient population Proactive, dependable, and eager to learn new skills Ability to balance multiple tasks and priorities throughout the day Professional, reliable, and eager to learn
Bachelor's degree OR 2 years of college in a health-related program OR completion of a medical assistant, phlebotomist, or other healthcare-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP required Experience as or certification/license as a CNA, Medical Assistant, Phlebotomist, or other direct-patient-care healthcare role required Experience with medical terminology and laboratory procedures helpful. Strong attention to detail, with the ability to collect, compile, and analyze patient data accurately. Excellent interpersonal, communication (verbal and written), and customer service skills. Easily able to learn new computer or website applications (i.e. Electronic Medical Records, Clinial Trial Management Systems, etc.) Proven ability to prioritize tasks, meet deadlines, and adapt to a fast-paced work environment. Problem-solving skills with a proactive and solution-oriented approach. Strong organizational skills with the proven ability to prioritize tasks and meet strict deadlines Phlebotomy training and experience heavily preferred; willingness to become fully trained required Why This Role is a Great First Step Gain hands-on experience working directly with patients in a clinical setting Learn the fundamentals of clinical research and how trials are conducted Build transferable skills for careers in healthcare, research, or biotechnology Work alongside experienced professionals who provide training and mentorship Create a strong foundation for advancement into roles like Clinical Research Coordinator or beyond Make a meaningful impact by helping bring new treatments and therapies to patients If you're looking to turn your academic experience into a meaningful, patient-focused career, this is a powerful place to start. 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 recruiting@headlandsresearch.com 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.
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