Senior Clinical Research ociate Philadelphia Pennsylvania REMOTE
Posted on :
10-09-2024
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1 Vacancy
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Job Description
Description
Senior Clinical Research Associate
Manage and monitor the progress of clinical studies at investigative sites or remotely and ensure clinical trials are conducted recorded and reported in accordance with the protocol standard operating procedures (SOPs) ICH/GCP and all applicable regulatory requirements.
Responsibilities:
Manage and monitor clinical trials independently across multiple studies to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelines
Provide input on clinical study documents such as Protocols ICFs Source Documents and Monitoring Plans
Initiate clinical trials at investigative sites instruct site personnel on the proper conduct of clinical trials and close clinical trials at investigative sites
Identify studyrelated issues confirm resolution and ensure proper documentation through event system
Record site visit activities including but not limited to observations of clinical conduct instructions/training given to sites and action items to be completed as required by OPs or other contractual obligations
Review and verify accuracy of clinical trial data collected either onsite or remotely including query resolution
Assist with generating contents list of Enrollment Kits and other Study Supplies as requested
Facilitate supply management and ensure clinical sites have necessary supplies to conduct studies according to applicable protocols
Assess IP accountability dispensation and compliance at the investigative sites
Ensure all required training is completed and documented
Perform essential document site file reconciliation
Ensure maintenance of essential documents in TMF to facilitate timely transfer to client
Serve as main contact for projectspecific communications with investigative sites
Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
Provide regular site status information to team members trial management and updates trial management tools
Participate in team meetings with clients as needed and keep project team members informed of study progress issues and potential timeline delays by preparing weekly updates as requested
Research and learn project indication
Serve as resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
Analyze process workflow; implement operational changes in coordination with Sr Management May be assigned additional Clinical Operations tasks
Help create a fun rewarding and collaborative environment
Education/Skills:
5 years of Clinical Research experience; IVD experience preferred
Bachelors degree in the Life Sciences or related field required or equivalent
Pursuing a certification as a CCRP or CCRA through recognized professional organization
Thorough knowledge of GCP GLP ICH guidelines and other U.S. and international clinical regulatory requirements
Strong work ethic and demonstrated ability to deliver assignments on time
Ability to travel (up to 80%)
Ability to handle difficult situations professionally and maintain a professional and caring demeanor
Proven ability to collaborate in a team environment and work independently
Must be a teamplayer punctual and reliable dependable and flexible in adapting to change in a multidisciplinary fastpaced work environment
Must be responsible creative and highly motivated
Works Closely With: CTAs Clin Ops Specialists CRAs Reg CRA Supervisors PMs Dir of Clin Monitoring & Data Management Sr Mgr of Clin Ops Dir of Clinical Programs
gcp,clinical trials,regulatory requirements,site management,team collaboration,tmf management,ich guidelines,clinical research,research,clinical monitoring
Employment Type
Full Time
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