The Clinical Data Entry Assistant will be based at ATC’s local office in Frederick, MD. This position is part-time with varying work hours between 8 and 20 hours per week. Will be supporting a government clinical trial to be conducted at Fort Detrick, MD. Duties include:
- Strong organizational skills, attention to detail and accuracy
- Excellent typing skills and proficiency in Microsoft Office programs
- Good interpersonal, communication and customer service skills
- Proficient literacy and numeracy skills
- Enter accurate and timely data in an Electronic Data Capture (EDC) Database system for clinical trial management.
- Ensures all activities conducted according to company and government Standard Operating Procedures and all applicable Good Clinical Practices (GCP) and International Council for Harmonization (ICH) regulations and guidelines.
- Position focuses on the integrity and quality of data to ensure research is conducted in accordance with GCP guidelines.
- Support data entry activities to meet study data needs and deadlines.
- Review source documentation and Case Report Forms (CRFs) for patients enrolled into clinical trials; enter precise and error-free source data into EDC database system.
- Maintain awareness of details of clinical data to identify missing or inaccurate data; flag data inconsistencies for Clinical Data Manager to review.
- Recognize, question, and detect any source data issues prior to entry of that data into sponsor EDC system.
- Types of data to be entered include patient medical history, vital signs, demographics, physical exam results, laboratory screening, sample history, local and systemic reactions, etc; data must be transcribed quickly and accurately from CRFs.
- Verify entries for accuracy and completeness.
- Assist Clinical Monitor and Quality Assurance Monitor with query resolution.
- Sign a Non-disclosure Agreement (NDA) and maintain strictest confidentiality.
- Contribute to the improvement of data management processes.
Education, Skills and Experience
- Bachelor’s degree preferably in a related science/biology field
- Knowledge of medical research program environment is desirable
- Strong computer literacy including knowledge of Microsoft Office Suite
- Experience with accurate data entry in cloud-based database systems preferably with clinical, medical or scientific data
- Ability to strictly adhere to procedures.
- Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data
- Strong customer focus and excellent interpersonal skills
- Proven flexibility and adaptability
- Must be able to set and meet timelines
- Knowledge of medical/clinical terminology
- Punctual and responsible with strong work ethic
- Extremely well organized
- Willingness to learn new tasks and grow with the company
About Allied Technologies and Consulting
Allied Technologies and Consulting, LLC is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
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Send Resume to Allied Technologies & Consulting, LLC
100 Tuscanney Dr., Ste. B2
Frederick, MD 21702.