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Company | Alcanza Clinical Research |
Address | Clermont, FL, United States |
Employment type | FULL_TIME |
Salary | |
Category | Research Services |
Expires | 2023-05-13 |
Posted at | 1 year ago |
Department: Operations
- Always practicing ALCOAC principles with all documentation;
- Filing SAE/Deviation reports to Sponsor and IRB as needed;
- Entering data in EDC and answers queries;
- Updating and maintaining logs, chart filings;
- Patient follow-up visits;
- May assist with study recruitment, patient enrollment, and tracking as needed;
- Obtaining vital signs and ECGs;
- Performing all other duties as requested or assigned.
- Scheduling subjects for study visits and conducts appointment reminders;
- Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
- Maintaining confidentiality of patients, customers and company information, and;
- Screening of patients for study enrollment;
- Building/updating source as needed;
- Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
- Requesting and tracking medical record requests;
- Patient consents;
- Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed;
- 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;
- Documenting in source clinic charts;
- Reporting non-compliance to appropriate staff in timely manner;
- May set up, train and maintain all technology needed for studies.
- Documenting and reporting adverse events;
- Maintaining & ordering study specific supplies;
- Maintaining positive and effective communication with clients and team members;
- Conducting monitoring visits and resolves issues as needed in a timely manner;
- 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:
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
- Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
- Well-developed written and verbal communication skills.
- Ability to work under minimal supervision, identify problems and implement solutions.
- Must possess a high degree of integrity and dependability.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
- Strong organizational skills and attention to detail.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, and supplemental insurance are offered.
- 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 hire.
- A 401k plan with an employer safe harbor match is also offered, with enrollment eligibility being the first of the month following 30 days of employment.
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