In-House Clinical Research Associate

Full Time
Posted
1 month ago

Essential Duties and Responsibilities

  • Support CTM in the execution and delivery of clinical trials to ensure they are completed on time and within budget.
  • Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan, or as needed.
  • Review Monitoring Visit Reports from the CRO and escalate monitoring trends or findings to the Study Manager.
  • Track metrics related to Sponsor Oversight and the Monitoring Plan.
  • Coordinates and participates in internal and external cross-functional clinical team meetings; May lead the meetings as needed.
  • Oversee and manage CROs, study contractors and vendors - including issue escalation/resolution and budget negotiations.
  • Responsible for collection of study metrics and develops reports and delivers presentations as requested.
  • Ensure that all vendor change orders are correct and processed within the timeline. 
  • Ability to track multiple items and provide guidance on the prioritization of tasks within a study, able to work with various groups internally and externally to get tasks completed Track and monitor day to day activities trials such as patient enrollment, data entry, protocol deviations, and other study matrixes. 
  • Provide internal support to clinical team to facilitate site identification/feasibility, site management and study closeout.
  • Flag potential issues for the clinical study manager and work with clinical team to resolve issues.
  • Work with clinical trial manager to develop study processes and procedures and then implement those process and procedures.
  • Interact with global clinical research organizations (CROs) and vendors to answer questions regarding study processes and procedures, as well as to monitor CRO activities.
  • Participate in clinical data review as part of the database cleaning process, issue data queries, and confirm responses.
  • Develop study documents such as informed consents, plans, and meeting materials.
  • Assist with the process of planning, preparation, and execution of study specific meetings, such as Investigator Meetings & Study Coordinator Meetings and present information at investigator meetings.
  • Assist clinical project team in preparation of audits/inspections and is responsible for the quality and completeness of clinical trial documentation.
  • As directed by Clinical Project Manager, may directly facilitate resolution of study related issues through communication with site personnel and clinical trial vendors.
  • Attend, prepare for and participate in regular Study Team meetings.
  • Maintain TMF according to SOPs for studies that are currently been worked on and legacy studies
  • Other duties may be assigned as deemed necessary by the Senior/Clinical Trial Manager.

 

Requirements

  • For In-house Clinical Research Associate 3-5 years in-house CRA experience (Biotech/Oncology-Hematology Experience is highly preferred). 
  • For In-house Senior Clinical Research Associate at least 4-7 years in-house CRA experience (Biotech/Oncology-Hematology Experience is highly preferred). 
  • Thorough understanding of ICH-GCP guidelines and their implementation in clinical trials.
  • University degree (equal to 4 years of college) in (para-) medical, pharmaceutical, sciences, life sciences or biosciences. Equally recognized degree and/or relevant experience may also be considered.
  • Strong organizational and communication skills are a must for this position.
  • The ability to handle multiple priorities within matrix environment is required.
  • Must possess the ability to work independently and be flexible but also able to follow processes and directions.
  • Good problem-solving skills are desirable as well as ability to make suggestions to improve efficiencies.
  • Fluent in English (written and spoken). Any other language is an asset.
  • Good computer skills: Word, Excel, PowerPoint, Outlook.
  • May require up to 30% travel.

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