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Clinical Trial Operations Opportunities at Parexel

Clinical Trial Operations

Research Associate

Job ID 53060BR Baltimore, Maryland
Essential Function
The Research Associate (RA) is responsible for completion of the required procedures in carrying out a clinical trial study protocol within an outpatient and/or inpatient environment, upholding Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) in completion of these tasks. These required procedures are included in the following areas of study conduct: subject recruitment, subject screening, subject enrollment, study subject participation and study closure.


Key Accountabilities
Including but not limited to the following and other duties as may be assigned:
Has detailed knowledge of the study protocols, lab manuals, and acceptable performance of quizzes.
Recruits study participants by calling the database, attending company sponsored community events, and involve in community recruitment including but not limited to posting flyers in schools, senior centers, supermarkets, and other establishments.
Enters study participants in the study participant tracking system, ClinBase, and study logs, maintains appointment calendars, and operates company information systems and computer programs.
Conducts screening visits and study protocol specific participant visits, assists staff physicians in assessment of concomitant medications, adverse events, lab results and other test results.
Performs appropriate psychometric and efficacy testing according to study protocol.
Receives authorized sign-off to verify accuracy of all study participant visits.
Receives authorized sign-off to verify accuracy of all study participant visits.
Responsible for ensuring the following: sample collection (e.g., drawing blood samples or
handling urine), processing, storage and shipment is according to protocol, lab manual or Sponsor provided documentation, following GCP and site SOPs to ensure accurate and complete data collection with documented Quality Control at each step.
Perform simple diagnostic laboratory tests (for example pregnancy tests, urinalysis, and drugs of abuse tests) according to current CLIA registration.
Assist with ensuring daily monitoring of laboratory storage equipment temperatures if automated monitoring system is unavailable for example during planned and unplanned power outages.
Prepares/monitors study supplies, stock levels, and equipment in clinic and lab, to ensure functioning properly, calibrated, and have updated maintenance records from (i.e., scales, ClinBase carts, freezers, mechanical pipettes, centrifuges, refrigerators etc.)
Identify and problem solves study-related issues as they arise, bringing to the attention of the CRC, CLC, QM and management as applicable.
Assumes appropriate role with study participants and caregivers including but not limited to safety, care, and customer service.
Attends and assists with site-initiation visit, start-up, study team, staff, and unit meetings.
Completes Case Report Forms (CRF) in a timely manner or per project-specific timelines.
Ensure quality assurance and accuracy of source and CRF documentation in real-time and throughout the study. Performs corrections for QM, CRC, CLC and Monitor/Sponsor Representative in a timely manner.
Assists with Monitor visits (i.e., room set up, query resolution, etc.).
Assists with maintaining and archiving research documents.
Maintains accurate accountability for petty cash.
Maintains and updates knowledge of ICH GCP and SOPs to ensure compliance and proper application in work.
Maintain a positive, results orientated work environment, building relationships with management, colleagues, and other departments, communicating in an open, balanced and objective manner.
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 is not to be considered as all inclusive

Qualifications

Skills
Demonstrated competency in all research-related tasks.
Strong interpersonal, written/verbal communication and organizational skills.
Must be able to work in a clinical setting with patients and study participants.
Knowledge and skill in techniques of good clinical judgment and good nursing care/adequate technical vocabulary (if LVN).
Ability to effectively manage time and multi-task.
Demonstrated knowledge and skills necessary to provide care appropriate to the age and/or indication of the study participants.
Ability to function well in a team environment.
Ability to train and give direction to other research associates and study team members.
Excellent customer service skills required.
Computer proficiency required.
Able to lift up to 20 lbs. if needed.
Able to stand or sit for long periods of time.
Able to view and work in front of a computer for long periods of time

Education
BS, BA in a related field or equivalent work experience.
Foreign MD or Master’s Degree a plus

Language Skills
English, English/Other
English, English/Spanish is a plus

Minimum Work Experience
Prior clinical research experience, floor nursing is a plus
Phlebotomy certification and maintenance of certification is a plus

EEO Disclaimer

PAREXEL is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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