Job Description

Comprehensive Research Solutions, LLC

Clinical Data Manager II

ESSENTIAL FUNCTIONS: (JOB FUNCTIONS INTRINSIC TO THE POSITION AND MUST BE PERFORMED WITH OR WITHOUT REASONABLE ACCOMMODATION)

Must have highly accurate recognition of clinical values and analytic skills to support data abstraction from source documents. Must be able to use databases to enter, validate, and report data. Must be able to organize and prioritize workload. Must possess strong written and verbal communication skills. Must be able to work both independently and with others.

PRIMARY DUTIES AND RESPONSIBILITIES (DUTIES AND RESPONSIBILITIES WHICH OCCUPY A MAJOR PORTION OF TIME AND IMPORTANCE IN THE JOB)

RESPONSIBILITY AND ACCOUNTABILITY SUMMARY

• Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions.
• Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously.
• Contribute to the design of the databases and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity.
• Assist research team in managing clinical research-related data
• Perform limited data abstraction
• Enter data into clinical databases or paper CRFs
• Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions
• Develop and run basic reports
• Assist with the review and quality control of Clinical Data Entry Specialists' work and provide guidance.
• Assist in the preparation, review, and submission of data to monitoring agencies.
• Understand and comply with core operating procedures and working instructions.
• Perform other duties as directed by Senior Clinical Data Manager, CDM Supervisor, and research team.
• Develop and maintain good communications and working relationships within ASRC CDM staff and government research team.

Required Experience:

• BS/BA (or the equivalent) in health-related field, and 3+ years' of related experience.
• Excellent organizational, communication, and computer skills required. Understanding of clinical research and medical terminology and ability to abstract data from source documents. Data entry and database experience required.

Preferred Qualifications:

• BA/BS degree/ 3 years of experience in a clinical/health-related field. Clinical data management or health-related certification (e.g., CCRP) a plus.

Please be aware that many of our positions require a security clearance, or the ability to obtain one. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information.

Job Types: Full-time, Contract

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person

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