Data Associate

Job Summary

Performs clinical and non-clinical data entry and validation to ensure accuracy, completeness and legibility of data. Assists users with requests for study related documents. Enters data into databases from internal and external sources. Maintains internal record keeping system(s) in conjunction with research studies. Maintains and audits data, providing status and activity reports as required. Maintains data management files for study protocol. Manages the CRF intake process utilizing DM’s DIA application. Communicates with site staff to resolve any discrepancies in CRF transmissions. Responsible for the accuracy of internal data entry processing. Uses data entry tools to enter clinical trial data. Creates and maintains patient files and archives containing all clinical trial data and related documentation.

Accountabilities:

• Responsible for the quality and maintenance of data entry. This includes reviewing and verifying data for accuracy and correcting any inaccurate data.
• Provides support for the department by completing data entry and providing data reporting information of appropriate databases as directed.
• Possesses knowledge of and remains compliant with FDA requirements and other related regulations regarding confidentiality and ethical issues of research subject data.
• Working with data management to validate designed functionality.
• Maintains study participant files and study notebooks.
• Provides support for the data query process.
• Researches Case Report Forms (CRF) data to ensure accuracy and completion of forms.
• Provides support for the data query process.
• Documents the status of queries generated and resolved.
• Assigns final statuses to queries.
• Enters revisions of approved and documented query changes to the clinical database.
• Inserts and modifies data in clinical databases from case report forms and other data collection instruments using clinical data collection systems.
• Logs incoming clinical trial documents and ensures that documents are correctly routed through the data operations and clinical trials groups.
• Maintains data management study files.
• Compiles requested information on patient files and clinical documentation for data operations and clinical personnel.
• Performs other related duties as assigned.

Applied Skills and Knowledge:

• Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
• Must be able to read, write, and speak fluent English, fluent in host country language.

Problem Solving & Impact:

• Works on assignments that are moderate in scope.
• Exercises judgment within defined and existing practices to determine specific work methods for obtaining results.
• Decisions may affect a work unit or area within a department.

Supervision Given/Received:

• Has no supervisory responsibility.
• Receives general instructions on new assignments.
• Contributes to process improvements that affect the department.
• Coordinates and interacts with internal and external staff on-site and in the field.
• Typically reports to a manager.

Education:

• Associate degree or International Equivalent in Data Management, Clinical Trials or Related Field.

Experience:

• 3-5 years’ experience with data entry and medical record keeping.
• Prior work experience in a non-governmental organization (NGO).

Technology to be Used:

• Personal Computer/Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment.

Typical Physical Demands:

• Typical office environment.
• Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
• Ability to sit and stand for extended periods of time.
• Ability to lift/move up to 5 lbs.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

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FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

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