PRN Research Assistant - overnight, weekend, and holidays

PRN Research Assistant – overnight, weekend, and holidays Part‑time position at Tranquil Clinical and Research Consulting Services LLC, Webster, TX, US. Summary The role of the part‑time Research Assistant (RA) is to support the clinical staff and patients. This clinic‑based position involves a variety of administrative tasks in support of clinical trials and assistance in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. The RA will assist Clinical Research Coordinators (CRC) and Research Nurses in conducting Phase I‑IV industry‑sponsored and investigator‑initiated clinical trials in accordance with trial protocols, FDA Regulations, and ICH/GCP Guidelines. The RA is accountable to the CRC/CRN and works with the study team to meet study‑specific goals and timelines, communicating effectively with internal staff and external collaborators. The RA assists with recruitment needs, maintains respectful relationships, and delivers outstanding customer service. To be successful, the RA should recognize logistical problems, initiate appropriate solutions, be detail‑oriented, multitask efficiently, collaborate with various role players, work independently, and proactively problem‑solve. Qualifications MUST HAVE relevant work experience in a clinical environment Must be able to work overnight, weekend, and some holidays Knowledge of clinical trials and medical terminology Basic computer skills: Microsoft Office Suite (Word, PowerPoint, Excel) Other skills required: Excellent time‑management and social skills Highly motivated with exceptional attention to detail Professional attitude in online workspace (proper email etiquette, attending remote meetings) Preferred: Basic Life Support (BLS) Other certifications applicable to clinical roles (medical assistant, medical technician, phlebotomy) Specialized knowledge of patients in the assigned therapeutic areas undergoing treatment Specialized knowledge of assigned therapeutic areas as it relates to research and clinical trials One to two years of experience in human life sciences/biomedical research (physiological, cellular, biochemical, or molecular biology) AA/AS or BA/BS in life sciences or equivalent educational background Work Environment Variable shifts: evenings, nights, and/or weekends Office‑based position; off‑site activity requires approval Workplaces include hospitals, medical clinics, and other medical institutions Willingness to wear Personal Protective Equipment (PPE) as required when visiting medical facilities or working in clinic Duties and Responsibilities Develop management systems and prepare for study initiation: Assess study feasibility regarding site resources, labor cost, procedure cost, and potential issues (serious AEs, non‑compliance, enrollment willingness, protocol deviations) Understand each assigned protocol in depth Review inclusion/exclusion criteria, structure, and requirements with the Principal Investigator Review protocol summary sheet and Informed Consent Form for accuracy and clarity Create draft follow‑up worksheets and review for accuracy and clarity Develop mechanisms for subject recruitment and ongoing communication with primary care physicians and nursing staff Screen and enroll study subjects: Review study design and inclusion/exclusion criteria with the subject’s primary physician Verify relevant source documentation in the subject's medical record to confirm eligibility Explain protocol, informed consent form, and follow‑up procedures to potential subjects Ensure approved informed consent is signed before screening and enrollment Follow randomization procedures per protocol guidelines Document protocol exemptions and deviations Manage study‑related activities, subject compliance, and documentation: Ensure adherence to protocol requirements Schedule subjects for follow‑up visits Assist investigators in assessment of subject response to therapy Review laboratory data, inform investigators of abnormal values, and document results Report to primary care provider as appropriate Assess and document subject compliance with medications and visits Communicate with pharmacy staff to assure timely and accurate study drug distribution Manage administration of investigational therapy Maintain dispensing logs (if permitted) Maintain copies of documentation for dispensing investigational products and study supplies Oversee specimen collection, storage, and shipment Attend study‑related meetings as appropriate Communicate regularly with the principal investigator, monitors, and other responsible personnel about study issues Record data and study documentation: Record data using the appropriate media or platform Follow electronic data entry procedures for access and security Review keyed data for accuracy as needed Send data to the data collection center promptly Maintain source documentation for all entered data, including clinic chart visits, lab data, and procedure reports Correct and edit data as directed and appropriate Monitor and report adverse events: Assess, document, and record all adverse events as outlined in the protocol Report serious adverse events to the Principal Investigator, Sponsor, and IRB (and others as required by funding source) Regulatory documentation: Understand all regulatory requirements associated with the assigned study Maintain files and documents as regulations dictate Prepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc.) and submit required reports Ensure all required documentation is complete and appropriately filed Management of site activities during audits and inspections: Prepare for quality assurance audits and regulatory inspections as needed Act as contact person before, during, and after audits and inspections Provide all required documentation to auditors Make corrections requested by auditors Coordinate site response to audit/inspection findings Management of ancillary staff: Train and supervise support staff (research assistants, clerical staff, volunteers) Night shifts (e.g., 3 PM‑11 PM, 11 PM‑8 AM) Weekends (depending on study) Holidays (depending on study) #J-18808-Ljbffr Tranquil Clinical and Research Consulting Services LLC