Job Description
About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary: Under moderate supervision, the Data Entry Coordinator I transcribes clinical research data correctly from source documents to electronic data capture following ALCOA-C principles.
Essential Responsibilities and Duties: - Ensures timely data entry thru department and study tracking, etc.
- Maintains healthy professional relationships with Clinical Operations, Quality, Regulatory, CROs, Sponsors, etc., as well key clinical trial personnel.
- Transcribes data accurately and efficiently from source documents to electronic data capture.
- Assists in preparing for internal and external data audits along with the clinical operations/ quality/ and regulatory teams.
- Completes training and obtains applicable certificates and access to CRFs/EDC.
- Verifies source documents (e.g., "buddy check").
- Assists CRCs in entering data from paper source documents to eCRFs correctly, accurately and on a timely manner for multiple clinical trials.
- Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills: - Minimum High School graduate or equivalent.
- One year of data entry or related preferred.
- Must have excellent computer skills and medical/research terminology.
- Must be self-directed and able to work with minimal supervision.
- Motivated to work consistently in a fast paced and rapidly changing environment.
- Able to manage multiple projects and responsibilities.
Working Conditions - Indoor, Office environment.
- Essential physical requirements include sitting, typing, standing, and walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
- On site work arrangement.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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CenExel
Job Tags
Full time, Work at office,