Clinical Research Data Analyst

JOB SUMMARY

• The Clinical Research Data Analyst hold data management and regulatory responsibilities relevant to Clinical Research. Data management refers to the day to day collection of data from patient medical records for submission to clinical study sponsors with minimal errors. In the event of identified errors, Clinical Research Data Analyst will oversee corrections. The position is also responsible for the collection and maintenance of federal regulatory documentation required for all Clinical Research studies and for submission to the IRB of record for the clinical study. Both responsibilities require the communication with research staff, Physician-investigators, study sponsors, and clinical offices internal and external to the organization. The Clinical Research Data Analyst is to ensure that department is compliant with policies and procedures affecting regulatory documents, review, approval, activation, regulation; along with the tracking and reporting of protocols; ensure appropriate processing and maintenance of all study related documents; and assist in the development of Standard Operating Procedures (SOPs) and to assist the efforts of the department's day to day operation. The Clinical Research Data Analyst will perform all other related duties as assigned.

GENERAL REQUIREMENTS

• Adheres to the hospital and departmental attendance and punctuality guidelines

• Performs all job responsibilities in alignment with the core values, mission and vision of the organization

• Performs other duties as required and completes all job functions as per departmental policies and procedures

• Maintains current knowledge in present areas of responsibility (i.e., self education, attends ongoing educational programs)

• Attends staff meetings and completes mandatory in-services and requirements and competency evaluations on time.

• Demonstrates competency at all levels in providing care to all patients based on age, sex, weight, and demonstrated needs. For non-clinical areas, has attended training and demonstrates usage of age- specific customer service skills.

• Background in medical technology.

WORKING CONDITIONS

• General environment: Works in a well-lighted, air-conditioned area, with moderate noise levels.

• May be required to change from one task to another of different nature without loss of efficiency or composure.

• Periods of high stress and fluctuating workloads may occur.

• May be scheduled as needed including overtime

EDUCATION REQUIREMENTS

• 4 year / Bachelor's Degree (Required)
• Master's Degree (Preferred)

EXPERIENCE REQUIREMENTS

• 2 year data collection and/or federal documentation or related experience (Required)

CERTIFICATIONS AND LICENSURES

• Certified Clinical Research Professional (CCRP-SoCRA) or Clinical Research Associates (CRA) obtained within 3 years of hire (Required)

GENERAL SKILLS

• Organizational Skills

• Communication Skills

• Interpersonal Skills

• Customer Relations

• Analytical

• Read / Comprehend Written Instructions

• Follow Verbal Instructions

• Transcription

• Basic Computer Skills

• Microsoft Office Suite

• General Clerical Skills

PHYSICAL REQUIREMENTS

• Have near normal vision

• Clarity of vision (both near and far), ability to distinguish colors

• Ability to perform - repetitive tasks/motion

PHYSICAL DEMANDS

• Standing

• Occasionally within shift (1-33%)

• Walking

• Occasionally within shift (1-33%)

• Sitting

• Continuously within shift (67-100%)

• Bending/Stooping

• Occasionally within shift (1-33%)

• Twist at waist

• Occasionally within shift (1-33%)

• Pushing/Pulling

• Occasionally within shift (1-33%)

• Reaching above shoulder

• Occasionally within shift (1-33%)