Clinical Research Coordinator Job at Alcanza Clinical Research in Portsmouth

Benefits

Qualifications

• •Minimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential AND 1+ years of clinical research coordination experience, OR an equivalent combination of education and experience, is required
• •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
• •Must possess a high degree of integrity and dependability
• •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
• •8 more items(s)

Responsibilities

• •The Clinical Research Coordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines
• •The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs
• •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
• •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, and;
• •Performing all other duties as requested or assigned
• •31 more items(s)