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Senior Clinical Research Associate

ExecuPharm - Australia,

Health, Medical & Pharmaceutical
Source: uWorkin


As a Functional Service Provider to a leading Medical Device Company-ExecuPharm (Parexel Company) is currently looking for a Senior Clinical Research Associate who would perform most their job responsibilities from their home office in Australia.

We will reward the right individual with a fully home-based, permanent role, excellent salary combined with a benefits package as well as many career progression opportunities.

This position provides oversight of clinical research sites compliance with ICH/Good Clinical Practices (GCP), governing SOPs (standard operating procedures) and clinical study protocols

Main responsibilities:

· Serves as the primary monitoring point of contact for assigned clinical research sites

· Performs site development and training (supporting and coaching site personnel), site set-up, site monitoring (evaluation of site performance and identification of issues), and site close-out activities for assigned clinical research sites with designated program SOPs, Client expectations, clinical study protocols and GCPs

· Problem solves (including CAPA development where necessary) identified issues with appropriate escalation to S&N CSM or Clinical Operations Manager and/or designees

· Assures protection of the rights, safety, and well-being of subjects, study integrity and data quality

· Performs activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, device accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution

· Facilitates the collection and maintenance of regulatory and site documentation for the Trial Master File and site file

· Manages Central and Local IRB or EC submissions including; workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB or EC in conjunction with study team/Client/site staff as applicable.

· Maintains awareness of site dynamics and able to motivate, persuade and educate site staff

· Complies with the Clinical Monitoring Plan and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the studies within the program

· Completes monitoring reports in compliance with requirements in the Clinical Monitoring Plan

· Completes training assigned by ExecuPharm/PAREXEL as applicable and/or the Client, as necessary, including general training requirements, SOPs, and system and process related training, and protocol specific training.

· Exhibits ability to proactively identify and interpret problems, recommend creative solutions, and influence appropriate changes

· May support more than one study, as required

· Complies with all objectives and metrics related to study and program execution

· Attend meetings as requested (i.e. investigator, study, program) to gain and/or share program/study/site knowledge

· If applicable to the CRA region, the CRA needs to speak and write the local language to be able to write/respond/assist with EC submissions/questions as directed by the CSM and as needed by S&N

Skills and Education:

· Bachelor’s degree required, degree in life science/medical background preferred. Equivalent work expertise is accepted.

· Minimum 5 years of monitoring experience

· 1 year medical device experience in Orthopedic, Sports Medicine, or Wound care preferred

· MediData RAVE, EC submission experience preferred

· Demonstrates solid understanding of clinical research practices

· Understands and is able to comprehend study protocols

· Possesses working knowledge of GCPs and other regulations governing clinical research

· Demonstrates technical expertise in computer skills

· Demonstrates diligent and self-motivated approach to working in an independent environment

· Demonstrates effective oral and written communication skills

· Ability to travel as required to meet program objectives

For an immediate consideration, please send your CV to the job poster. We look forward to hearing from you!