Job Specifications
Senior Clinical Research Associate – CONTRACT (min. 3-6 months)
Dallas, Texas -USA (site location)
The Company:
Late-stage autoimmune company focused on developing and commercializing small molecule therapies.
The Role:
The full-time Senior Clinical Research Associate will be an integral member of the Clinical Operations team whose work drives the company to meet critical milestones in the company’s clinical development programs. The successful candidate will be self-motivated, comfortable working in a start-up environment where everyone pitches in to realize company goals, flexible, and innovative.
Must have experience managing sites in late-stage clinical trials, knowledge of clinical operations, ICH/GCP and FDA regulatory requirements. Travel Requirements:
Travel can range from 75%
Responsibilities:
Ensure compliance with study protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, CRA oversight visits, maintenance of study files, study close out, and retrieval of study materials
Support the sponsor and CRO study team in meeting study milestones (site activations, database lock, Investigator Meetings, etc.)
Support centralized monitoring activities between on-site visits to ensure timely resolution of action items, oversight of study data quality and flow, and proactively identify and mitigate/manage study risks and issues
CRA will work closely with a cross-functional team in a fast-paced high growth environment to ensure that clinical trials are conducted on time and within budget, and in accordance with applicable GCP/ICH guidelines, other regulatory requirements, and SOPs.
Partner efficiently, effectively, and professionally with participating study sites and vendors to ensure smooth study conduct.
Provide study and/or site-specific progress updates to Clinical Operations Leads and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
Provide oversight support in the timely recruitment of trial participants with subsequent efficient and effective data management.
Provide monitoring oversight through review of monitoring schedules, metrics, and reports.
Participate and support the study team and Investigator sites in audit preparation and follow-up activities, as needed
Support the development of study documents and tools, including study logs, manuals, templates, newsletters, and other documents, as needed.
Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans.
Coordinate and conduct data reviews and data cleaning activities.
Tracking of ancillary and investigational supplies, specimens and/or imaging.
Ensure compliance with ICH/GCP and global regulatory guidelines.
Must be willing to travel within the United States and internationally (as needed).
Experience And Qualifications
Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
Minimum of 4-6 years of clinical trial experience including vendor management experience (e.g., imaging, central lab, IRT) and clinical monitoring in pharmaceutical, biotech or CRO setting.
Experience in late-stage clinical trials, including global experience.
Experience working in small/emerging biotech is ideal
Willingness to be a “team player” and take on additional responsibilities as requested
Thorough knowledge of drug development, clinical operations processes and procedures according to ICH/GCP and other regulatory guidelines.
Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
Able to recognize need(s), find solutions, and take initiative to address in pro-active manner.
Strong organizational, time management, skills.
Excellent communication skills, both oral and written.
Strong collaborator with demonstrated record of success in a cross-functional team and fast- moving environment.