Senior Clinical Research Associate

5 days ago

Los Angeles, California, United States Embakire Full time
Job Description

**Job Summary**

We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team at Embakire. As a key member of our clinical operations team, you will be responsible for managing and monitoring clinical studies at investigative sites or remotely, ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.

Key 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 study-related 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 project-specific 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.

Requirements:

  • 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 team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment.
  • Must be responsible, creative and highly motivated.

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