Data Coordinator (EDC)

Posted 13 Days Ago
Be an Early Applicant
Decatur, GA, USA
In-Office
Junior
Healthtech • Biotech • Pharmaceutical
The Role
Enters and reviews clinical trial data in EDC and related systems, verifies patient records against eCRF and protocol requirements, reports discrepancies, supports clinical research activities, and maintains compliance with GCP, ICH, HIPAA, FDA regulations, SOPs, and confidentiality standards.
Summary Generated by Built In
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.

About
Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life. Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined. Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.

Skills Required

  • High school diploma or equivalent
  • At least 1 year of clinical data entry experience, or equivalent combination of education and experience
  • Proficiency with Microsoft applications, email, and web applications
  • Typing proficiency of at least 40 words per minute
  • Strong organizational skills and attention to detail
  • Strong written and verbal communication skills
  • Strong interpersonal and listening skills; ability to work independently and collaboratively
  • Ability to manage multiple tasks and adapt to changing workloads and priorities
  • Professionalism, self-motivation, strong work ethic, integrity, and dependability
  • Ability to handle sensitive information confidentially and comply with HIPAA guidelines
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The Company
1,000 Employees
Year Founded: 2021

What We Do

Alcanza Clinical Research is an integrated U.S. network of clinical research facilities focused on reducing barriers to participation, particularly for underrepresented patient populations. It provides full-scale Phase I–IV trial capabilities across multiple therapeutic areas, serving pharmaceutical sponsors and contract research organizations. Its network combines dedicated research units with sites embedded in specialty clinics, helping make clinical trials more accessible while supporting studies across trial phases.

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