Clinical Research Assistant II

Working under the supervision of a Senior Research Assistant, Manager or Principal Investigator and following established policies and procedures, provides assistance on clinical research studies.

Principal Duties and Responsibilities

• Collects and organizes patient data

• Maintains records and database

• Uses software programs to generate graphs and report

• Recruiting patients for clinical trials, conducts phone interviews and schedules patients for visits.

• Obtains patient study data from medical records, physicians, etc.

• Conducts library searche

• Performs administrative support duties as required

• Verifies accuracy of study form

• Updates study forms per protocol

• Prepares data for analysis and data entry

• Assists with formal audits of data

• Documents patient visits and procedure

• Assists with regulatory binders and QA/QC procedures.

• Assists with interviewing study subject

• Administers and scores questionnaire

• Provides basic explanation of study and in some cases obtains informed consent from subject

• Performs study procedures such as phlebotomy

• Assists with study regulatory submission

• Writes consent form

• Verifies subject inclusion/exclusion criteria

• Assists with determining suitability of study subject

• Maintains research data, patient files, regulatory binders and study database

• Performs data analysis and QA/QC data check

• Organizes and interprets data

• Has input into recruitment strategie

• Acts as study resource for patient and family

• Monitors and evaluates lab and procedure data

• Administers/scores/evaluates study questionnaire

• May contribute to protocol recommendation

• Assists with preparation for annual review

• Assists PI to prepare complete study reports & presentation

Qualifications

• Education; Bachelor's Degree

• Experience: Minimum 1-year related post bachelor's degree experience required

EEO Statement

McLean is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.