Senior Clinical Research Associate (Sr. CRA) Clinical Development

Senior Clinical Research Associate (Sr. CRA)
Clinical Development


Scope of Responsibilities
The Senior Clinical Research Associate is assigned to one clinical trial and a clinical trial team and leads various clinical operational aspects of the trial management in collaboration with other clinical team members. Responsible for providing expert and overall support to clinical study teams in matters related to vendor oversight, investigational site management and other study related activities, including; study start-up, vendor selection and management, interim study monitoring and management as well as trial closeout activities.

Duties (may include but are not limited to):
• Perform onsite monitoring activities and/or ensure adherence to the clinical monitoring plan
• Manage study sites and train the clinical site staff to ensure protocol and regulatory compliance and quality of data
• Independently oversee external CRAs, providing clear communication and direction with regards to the clinical protocol and general trial support
• Participate in the CRO selection and management
• May assist in or be responsible for development of protocols, informed consents, case report forms, monitoring plans, edit specifications, and clinical study reports
• Assist with projection and management of clinical supplies
• Coordinate and/or participate in investigator meetings
• Responsible for updating study timelines and metrics
• Responsible for listing review and resolution of queries during database lock and in preparation of final study reports
• Participate in and/or chair meetings or conference calls with CROs, CRAs and cross-functional study teams
• Provide mentoring to CRAs and Clinical Trial Assistants (CTA’s)

Requirements:
• Bachelor’s degree in a relevant scientific discipline or equivalent
• At least 5 years of relevant experience with at least 2 years in a CRA functional role in the pharmaceutical industry, Biotech or equivalent
• Knowledge of GCP and ICH guidelines required
• Excellent communication and interpersonal skills
• Detail and quality oriented
• Able to work independently and within a team
• Able to perform assignments with general instructions
• Able to solve complex problems, prioritize multiple tasks, plan proactively and accomplish goals within project
• Experience developing tools and processes that increase measured efficiencies of the project
• Strong computer skills in MS Word, Excel, Outlook, and PowerPoint
• Must be willing to travel (25 -30%)