Research Associate II

Job Description :

Key Accountabilities

Including but not limited to the following and other duties as may be assigned:

• Has specialized skillset experience, and/or certifications, such as but not limited to experience with fMRI (functional Magnetic Resonance Imaging), psychometric ratings, Licensed Vocational Nurse licensure, etc.

• Has clinical operations experience such as but not limited to Research Associate I role or equivalent.

• Assumes appropriate role with other study team members and provide directive and training to new Research Associates and Study Team Members.

• Has detailed knowledge of the study protocols.

• 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.

• Prepares/monitors study supplies and stock levels in clinic.

• Labels, inventories and sends plasma samples.

• Identify and problem solves study-related issues as they arise, bringing to the attention of the CRC 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 and Monitor/Sponsor Representative in a timely manner.

• Complies with ICH GCP and departmental guidelines.

• 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.

• Exhibits professional demeanor at all times.

• Maintains supportive, flexible manner internally with management, coworkers/team members.

• Maintains and updates knowledge of Standard Operating Procedures and their proper application.

• All other duties as assigned.

QualificationsSkills

• For RA II with experience: extensive experience and understanding of the Research Associate I role or other equivalent experience with 6 months to 1 year of prior experience.

• For RA IIs with skill sets: extensive experience and understanding of the specific skill set(s) with 6 months to 1 year of prior experience.

• 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.

• BSN, RN, LVN, foreign MD or Masters Degree a plusEEO DisclaimerParexel 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.