FSP Senior Clinical Research Associate
Parexel International Corporation
USA - Any Region - Home Based
ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.
Job Title: Senior Clinical Research Associate (Sr. CRA)
This position provides oversight of clinical research sites compliance with ICH/Good Clinical Practices (GCP), governing SOPs (standard operating procedures) and clinical study protocols.
· Reports to EP assigned Clinical Operations Manager
· Interfaces with cross-functional study team members in a matrix environment (i.e. data management)
· 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 Client’s 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 ClientQualificationsSkills 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 objectivesEEO 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.