Clinical Research Assistant

Job DetailsJob Location: SANDY SPRINGS - Sandy Springs, GA 30328JOB SUMMARY The Clinical Research Assistant supports the conduct of clinical trials under the direction of the Clinical Research Manager and Principal Investigator. This position rotates across three functions: participant and visit support, regulatory document management, and clinical data management. All duties are performed in accordance with the approved protocol, ICH E6(R3) Good Clinical Practice, applicable FDA regulations, and site standard operating procedures. The incumbent performs only those study tasks formally assigned on the Delegation of Authority Log with training documented in advance. ESSENTIAL DUTIES AND RESPONSIBILITIES Participant and Visit Support (approximately 50 percent) Prescreen the clinic schedule and medical records against protocol eligibility criteria and maintain the prescreening log. Prepare visit packets, room participants, and collect vital signs, medical history, concomitant medications, and adverse event information under supervision. Perform protocol-specified study procedures consistent with training and certification and obtain required study certifications. Present the informed consent form and route the discussion to the investigator or delegated coordinator. May obtain consent independently only after documented delegation and competency sign off. Track visit windows, schedule visits, and conduct participant reminder and retention outreach. Support investigational product accountability, including dispensing logs and storage temperature documentation. Escalate any participant safety concern to the coordinator and investigator the same business day. Regulatory and Compliance Support  (approximately 25 percent) Maintain the investigator site file, including filing, version control, and completeness checks. Prepare IRB submissions, continuing reviews, amendments, and deviation reports for coordinator and investigator review. Maintain the delegation log, training records, licensure, and financial disclosure documentation, and flag expiring documents in advance. Support sponsor initiation, monitoring, and close out visits and track action items to closure. Data and Documentation  (approximately 25 percent) Complete source documentation contemporaneously and accurately, consistent with ALCOA+ principles. Enter data into the electronic data capture system within five business days of the visit and resolve assigned queries. Reconcile laboratory, imaging, adverse event, and concomitant medication data against the case report form. Process, label, store, and ship biological specimens per the laboratory manual and applicable shipping regulations. Maintain enrollment, screen failure, and participant identification logs with strict confidentiality. QualificationsQUALIFICATIONS Required High school diploma or equivalent. Associate or bachelor degree in a life or health science preferred. One year of patient facing healthcare experience, or an equivalent combination of education and experience. Demonstrated accuracy with detailed documentation and comfort working within defined procedures. Proficiency with electronic health records and web based systems, with the ability to learn new platforms quickly. Ability to communicate clearly and compassionately with patients across a wide range of ages and health literacy levels. Ability to maintain strict confidentiality of protected health information and study data. Flexibility to accommodate occasional early, extended, or weekend visits required by protocol. Preferred Certified Ophthalmic Assistant or Technician, or comparable clinical certification. Prior clinical research exposure in any capacity. Phlebotomy certification and Basic Life Support certification. Bilingual capability appropriate to the patient population served. Required Training Good Clinical Practice and human subjects protection within 14 days. HIPAA within 7 days. Site standard operating procedures and OSHA safety within 30 days. Basic Life Support and shipping certification within 90 days. Protocol and system specific training before the associated task is delegated. Professional certification through ACRP or SOCRA is supported once eligibility is met. Physical Demands and Work Environment Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Frequently sits, stands, and moves between exam lanes, imaging areas, and office space for extended periods. Occasionally lifts and carries supplies and shipping containers weighing up to 25 pounds. Requires close visual acuity for data entry and equipment operation, and clear verbal communication with participants. Outpatient clinic environment with potential exposure to biological specimens and diagnostic agents. Personal protective equipment is provided and required. Standard schedule Monday through Friday during clinic hours, with occasional protocol driven variation. Acknowledgment This job description describes the general nature and level of work performed and is not an exhaustive list of all duties, responsibilities, or qualifications. It does not constitute an employment contract and may be modified at any time. Thomas Eye Group is an equal opportunity employer and provides reasonable accommodation to qualified individuals with disabilities.