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Clinical Research Coordinator

Company: PAREXEL
Location: Lakewood
Posted on: September 17, 2020

Job Description:

Including but not limited to the following:

Reviews and understands the study protocol, proactively seeking to identify and address questions and operational risks with Project Manager and/or sponsor to ensure successful execution of studies; including but not limited to Inclusion/Exclusion criteria, lab materials or requirements, equipment needs, result turnaround times, screening materials, and ClinBase or source requirements.

Responsible for study resource allocation, maintaining timely resource requests and optimizing efficient and effective planning and utilization of resources.

Responsible for ensuring study team training compliance with protocol and any other study procedure/task required trainings, arranging and providing trainings as appropriate to ensure study team members are oriented and understand tasks to be performed.

Responsible for establishing and ensuring timelines relating to area of responsibility are met.

Responsible for data quality and protocol compliance excellence demonstrated in study start up, execution, and closeout through accuracy in ClinBase or paper source, ensuring source data entry completeness and adherence to GCP, meeting study timelines.

Responsible for ensuring procedure coverage and task execution, coordinating with other departments to optimize efficiency in execution.

Responsible for creating study specific paperwork and or materials as needed.

Communicates with physicians and relevant Clinical Staff in evaluating study participant status.

Responsible for monitoring study participant test results, including but not limited to Adverse Events, laboratory, vitals, ECG, and other procedure results, escalating any protocol, safety or other concerns as appropriate to medical group and management.

Attends outside Investigator meetings as requested (may require travel) and in-house Investigator meetings.

Responsible for oversight with monitors, proactively seeking to ensure preparation for the visit with study materials, establishing study team presence and coverage, to expedite and address query, question and or issue resolution as soon as possible.

Responsible for overseeing clinical trial volunteers according to protocol specific requirements and CFR/ICH GCP guidelines. Ensure all study laboratory and medical tests are completed and the eligibility requirements specific to assigned studies are met.

Ensure quality control (QC) performance of all electronic and paper source documents.

Responsible for overseeing Visit Tickets updates and sign off to ensure finance has metrics per required timelines.

Maintains and updates knowledge of SOPs and their proper application.

Oversees potential study participant scheduling.

Oversees potentially study participant enrollment activities, tracking enrollment status and overseeing maintenance of the enrollment log, planning and managing operational subject screening flow to optimize visits, QC screening charts, managing data entry and QC, and providing PM and or sponsor updates as needed.

Oversee study data entry and QC, ensuring sponsor timelines are upheld through timely data entry, query resolution, and data transfers, communicating updates to PM.

Oversees study team to ensure Glendale Medical Adventist Center (GAMC) subject requirements for dietary, admission and safety are collected and provided to GAMC in a timely manner.

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 inclusiveQualificationsDemonstrated leadership ability.

Excellent interpersonal, verbal and written communication skills.

Client focused approach to work.

A flexible attitude with respect to work assignments and new learning.

Ability to effectively manage time with multiple and varied tasks with enthusiasm, prioritizing workload as needed.

Attention to detail.

Willingness to work in a matrix environment and to value the importance of teamwork.

Knowledge and skill in techniques of ICH GCP.

Demonstrable knowledge and skills necessary to provide care appropriate to the age and/or indication of the study participants.

BS, BSN, RN, LVN, or foreign MD, MS, MA, PhD preferred.EEO 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.

Keywords: PAREXEL, Los Angeles , Clinical Research Coordinator, Healthcare , Lakewood, California

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