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Skills: Clinical data entry, Data management, GCP compliance, ICH guidelines, HIPAA compliance
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North Charleston, South Carolina, United States · On-site
Entry level$4M raised
EMT / Paramedic - Weekday evenings (Between 7pm-7am) and weekend shifts needed - PRN Department: Operations Employment Type: Part Time Location: Coastal Carolina Research Center | Charleston, SC Reporting To: Mary Love D…
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Skills: Patient Screening, Patient Consent, Phlebotomy, ECG Performance, EDC Data Entry
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Full-time
high school
Medical, Dental, Vision, Life insurance, Short and long-term disability insurance, Health savings accounts
Posted 1d ago
~40 hrs/week
Responsibilities
The Data Entry Coordinator is responsible for entering clinical visit data into EDC systems and ensuring all documentation complies with GCP, HIPAA, and FDA regulations. They also review patient charts to maintain accurate records and report any study irregularities to the appropriate parties.
Requirements
Candidates must have a high school diploma or equivalent and at least one year of clinical data entry experience. Proficiency in computer applications and the ability to type at least 40 words per minute are required.
Full job description
Healthcare Data Entry Coordinator
Department: Operations
Employment Type: Full Time
Location: Coastal Carolina Research Center | Charleston, SC
Reporting To: Nikki Shebelskie
Description
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Data Entry Coordinator works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs.
Key Responsibilities
Essential Job Duties:
In collaboration with other members of the clinical research site teamwork to ensure the entry of clinical visit data in EDC and other clinical data software/systems. Responsibilities may include but are not limited to:
Managing data entry into computer systems for clinical trials, including entering patient data into eDC and other software
Reviewing patient charts and other medical records to ensure data is entered in a timely manner in accordance with eCRF guidelines and protocol requirements
Reporting any irregularities or problems with a study to the appropriate parties
Supporting other clinical research-related activities
Ensuring compliance with SOPs, regulations, ICF documentation, and GCP/GDP guidelines
Maintaining confidentiality of patients, customers, and company information, and performing other related activities as assigned.
Skills, Knowledge and Expertise
Minimum Qualifications: High School diploma or equivalent and a minimum of 1 year of clinical data entry experience, or an equivalent combination of education and experience. Required Skills:
Proficiency with computer applications such as Microsoft applications, email, and web applications, and the ability to type proficiently (40+ wpm);
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 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.
At Alcanza℠, we believe in the power of clinical research to move healthcare forward for all patients. Because research is the first step in bringing approved treatments to market, we encourage everyone to learn more about participating.
At Alcanza℠, we believe in the power of clinical research to move healthcare forward for all patients. Because research is the first step in bringing approved treatments to market, we encourage everyone to learn more about participating.