Clinical Protocol Analyst (Clinical Research Associate)

BASIC JOB FUNCTIONS (SHORT SUMMARY OF THE PURPOSE OF THE JOB)

Provide advanced technical expertise as part of a team to develop and maintain clinical systems. Plan and coordinate database design and development. Research, analyze, and implement clinical systems and databases. Determine user and system requirements and design, test, and integrate clinical systems and software. Provide training to staff who will be responsible for using the systems.

ESSENTIAL FUNCTIONS: (JOB FUNCTIONS INTRINSIC TO THE POSITION AND

MUST BE PERFORMED WITH OR WITHOUT REASONABLE ACCOMMODATION)

Must be able to read, write, research, analyze, report, and communicate highly technical information clearly, accurately, and professionally. Excellent attention to detail required. Ability to act independently and with initiative required to resolving problems.

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

RESPONSIBILITY AND ACCOUNTABILITY SUMMARY

-Research, analyze, plan, and coordinate database design, development, implementation, maintenance, and user support of clinical systems.

-Design, test, and integrate clinical systems and software databases in accordance with research protocol, programming standards and validation procedures.

-Determine user and system requirements and compile specification document for each protocol

-Interface with clinical teams to understand and gather requirements

-Specify schema, forms, and procedure requirements for each study

-Lead protocol builders meetings

-Participate in Configuration and Change Management Groups (CCMG) meetings as requested

-Provide technical expertise in conjunction with internal and external clients.

-Program database manipulation and transfers of data for internal and external clients.

-Generate clinical reports based on team needs

-Participate in training CDM and clinical personnel

-Generate documentation

-Mentor other team members in training and developing technical and/or database expertise.

-Independently bring project solutions to the Informatics and Clinical Data Management groups.

-May assist in developing and implementing new technologies.

-May assist IT in testing and evaluating new upgrades to technologies.

-May assist in developing, revising, and maintain core operating procedures and working instructions.

-Interact with the project team to organize timelines, responsibilities, and deliverables.

-Develop and maintain good communications and working relationships with teams and external clients.

Job Type: Full-time

Benefits:

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

Work Location: Hybrid remote in Bethesda, MD 20814