Clinical Research Coordinator
Posted on: September 17, 2020
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
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
Responsible for creating study specific paperwork and or materials
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
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
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
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
Excellent interpersonal, verbal and written communication
Client focused approach to work.
A flexible attitude with respect to work assignments and new
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
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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