Travel Clinical Research Coordinator

Key Responsibilities

• In collaboration with other members of the clinical research site team works to ensure the execution of assigned studies.
• Under The Direction Of The Site Manager/Director And The Principal/Sub Investigators, Conducts The Following According To Study Protocol, Company Processes & Procedures, And In Compliance With FDA, GCP, ICH Regulations And Guidelines
• Screening of patients for study enrollment;
• Patient consents;
• Patient follow-up visits;
• Documenting in source clinic charts;
• Entering data in EDC and answers queries;
• Obtaining vital signs and ECGs;
• May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
• Requesting and tracking medical record requests;
• Updating and maintaining logs, chart filings;
• Maintaining & ordering study specific supplies;
• Scheduling subjects for study visits and conducts appointment reminders;
• Building/updating source as needed;
• Conducting monitoring visits and resolves issues as needed in a timely manner;
• Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
• Filing SAE/Deviation reports to Sponsor and IRB as needed;
• Documenting and reporting adverse events;
• Reporting non-compliance to appropriate staff in timely manner;
• Maintaining positive and effective communication with clients and team members;
• Always practicing ALCOAC principles with all documentation;
• Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc;
• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;
• Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed;
• Assist with training of new research assistants and coordinators;
• Assist with scheduling and planning for visit capacity for assigned studies;
• May set up, train and maintain all technology needed for studies;
• May assist with study recruitment, patient enrollment, and tracking as needed;
• May handle more complex study assignments and volumes;
• May participate in community outreach / education events;
• Maintaining confidentiality of patients, customers and company information,
• Performing all other duties as requested or assigned.

Skills, Knowledge And Expertise

• Minimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential AND 2+ years of clinical research coordination experience, OR an equivalent combination of education and experience, is required.
• Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred.
• Vaccine trial experience is required.
• Bi-lingual (English / Spanish) proficiency is a plus.
• Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);
• Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
• Strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills.
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
• Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
• Must be professional, respectful of others, self-motivated, and have a strong work ethic.
• Ability to work under minimal supervision, identify problems and implement solutions.
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

Benefits

• Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
• Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.