Job Abstract

Work as an integral member of investigator site staff managing the day-to-day coordination and execution of clinical studies in accordance with the protocol, contracted scope of work, good clinical practice, sponsor and Avacare standard operating procedures (SOPs) and any relevant local guidelines and regulations.

• Provide clinical research support to investigators to prepare for and execute assigned research studies
• Review study protocols, source document forms, other study-specific documents, and electronic data capture systems used to record clinical research data
• Collect and submit regulatory/ethics documentation as required by the Federal Drug Administration (FDA) and other regulatory bodies governing the conduct of the study
• Recruit and screen patients for clinical trials and maintain subject screening and enrollment logs
• Orient research subjects to the study including the purpose of the study, procedures and protocol requirements such as timeline for visits
• Maintain source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles
• Schedule and execute study visits and performs study procedures as delegated and supervised by the Principal Investigator
• Handles lab testing and analysis including preparation of specimen collection tubes and lab logistics
• Monitor subject safety and reports adverse events and reactions to Principal Investigator, study team members  and institutional review boards (IRBs) as appropriate
• Correspond with research subjects to troubleshoot study-related questions or concerns
• Participate in routine meetings with site study staff and Investigators to confirm study tasks are assigned and are executed to the expected standards
• Actively involved in study data quality checking and query resolution
• Perform a variety of complex clinical research procedures including but not limited to electrocardiogram (ECG), lab sample collection, spirometry, vital signs, dose verifications, cardiac telemetry monitoring, and questionnaire administration
• Assist investigator in verifying that research study objectives are met on time, within budget and according to application protocol requirements, clinical research regulations and quality standards
• Assist in providing training to new investigator site staff members on study-specific topics and requirements
• Maintain adherence to investigator site staff training requirements by auditing and maintaining training records
• Prepare for and as needed attend study monitoring visits, study audits and regulatory inspections with clinical research regulatory agencies
• Adhere to standard operating procedures (SOPs) and other directives throughout this process

•  Degree in health care or other scientific discipline preferred
• At least 1 year experience working in a clinical research setting preferred.
• Equivalent education and experience - High School Diploma and 3 years' relevant work experience in a clinical environment or medical setting, e.g. medical assistant, laboratory technician.
• Working knowledge of clinical trials.
• Working knowledge of the principles of Good Clinical Practices (GCP).
• In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules.
• Skill in carrying out required clinical procedures.
• Working knowledge of medical terminology.
• Ability to pay close attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians and clients.
•  Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies.