Clinical Research

• Lead the operational delivery of assigned clinical trials, ensuring milestones, timelines, budget expectations, and quality standards are achieved
• Drive study start-up activities, site activation, enrollment strategies, and study execution through database lock
• Provide oversight of study progress, monitoring activities, clinical metrics, and site performance
• Develop and implement effective study oversight plans, monitoring strategies, and risk mitigation approaches
• Identify operational challenges and proactively implement solutions to ensure successful study delivery
• Build and maintain strong relationships with sponsors, investigators, vendors, and cross-functional stakeholders
• Review study performance metrics and provide regular status updates and reporting
• Support, mentor, and collaborate with Clinical Research Associates (CRAs) and other study team members
• Ensure all clinical trial activities comply with protocol requirements, ICH-GCP guidelines, and applicable regulatory requirements

Senior Clinical Trial Manager

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH Good Clinical Practice (GCP) guidelines.
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites.
• Performs site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations.
• Reviews and verifies accuracy of clinical trial data collected onsite or remotely.
• Provides regular site status information to team members and trial management and updates trial management tools.
• Completes monitoring activity documents as required by sponsor SOPs.
• Works with clinical team members to resolve trial and clinical issues.
• Escalates site and trial-related issues until resolved or closed.
• Performs essential document site file reconciliation, source document verification, and query resolution.
• Assesses investigational product accountability, dispensation, and compliance.
• Verifies serious adverse event reporting according to trial specifications and ICH GCP guidelines.
• Communicates with investigative sites and updates applicable tracking systems.
• Ensures required training is completed and documented.
• Functions with little oversight at the senior level and may serve as a subject matter expert.
• May be assigned complex studies and/or sites.
• Provides leadership to assigned clinical operations projects.
• Serves as observation and performance visit leader.
• Interacts with other functional areas to resolve site issues and facilitate trial timelines.

Senior Clinical Research Associate

• Provide statistical support as a consultant or collaborator to clinical and research investigators and administration
• Provide consultative research support to investigators within and outside their departments
• Provide statistical expertise for research efforts
• Recommend optimal study designs
• Develop statistical analysis plans
• Interpret findings and prepare written technical and statistical reports
• Assist in developing research topics with internal and external investigators to support funding, peer-reviewed publications, and national meeting presentations
• Direct biostatistical and/or data analysts in planning and implementing analyses, summarizing results, and reporting findings
• Design, manage, and analyze databases
• Provide data analysis and summary reports
• Participate in committees
• Perform critical reviews of competitive protocol submissions
• Provide continuing education to staff
• Provide resource materials and brief consultations upon request

Biostatistician

• Serve as the primary point of communication for assigned trial sites and facilitate internal client teaming to drive issue resolution
• Maintain relationships with critical site stakeholders and provide a voice for sites to client teams
• Contribute to site feasibility, site qualification visits, follow-up, and final site selection
• Coordinate local team activities, recruitment planning, contingency and risk management, budget forecasting, and study-level documentation
• Engage investigators and site staff throughout the trial and communicate status information and issues to stakeholders
• Maintain and update trial management systems and analyze trial progress
• Initiate corrective and preventive actions when trials deviate from plans
• Contribute to site-level recruitment strategy and contingency planning
• Manage country-level vendors, invoices, local study supplies, and vendor selection requests
• Conduct local trial team meetings and facilitate monitoring training
• Prepare and manage country- and site-specific informed consent forms
• Ensure adverse events, serious adverse events, and product quality complaints are reported within required timelines
• Maintain inspection readiness, essential documents, CTMS and eTMF/IF data, and archive records
• Ensure site data quality and timely query resolution
• Support CAPA implementation for audits, inspections, and quality visits
• Ensure accurate finance reporting and proactive country/local budget management
• Organize IEC/HA approvals with the local Start Up team
• Provide systems/process training and contribute to process initiatives
• Complete timely and accurate time reporting
• Manage complex Early Phase trials with internal matrix clinical teams and sites

• Oversee the day-to-day activities of clinical trials in accordance with Good Clinical Research Practice (GCP)
• Run portions of clinical trials from startup to closeout
• Coordinate screening, recruiting, enrolling, and consenting
• Conduct feasibility planning, data management, and biological specimen management
• Prepare for monitoring visits and prepare regulatory and IRB documents
• Ensure study procedures comply with protocols and applicable regulations
• Train and supervise research staff on clinical trial procedures and GCP
• Maintain subject logs, track expenses, and submit monthly payment documentation to the Grant Administrator
• Perform quality control assessments and organize clinical trial data documentation
• Design electronic capture databases when appropriate and manage collected data
• Assist with staff orientation, workflow development, training documents, SOP/guidance document revision, and work groups

Senior Clinical Research Coordinator

• Recruit, screen, consent, and enroll participants
• Schedule and conduct in-person and remote study visits
• Administer surveys and structured interviews
• Distribute and track study devices and participant compensation
• Collect and enter data
• Follow IRB and human subjects policies and regulations
• Develop, update, and manage study-related materials and documentation
• Communicate with participants
• Perform other research duties as needed
• Work directly with the study principal investigator and senior Clinical Research Coordinator
• Clinical Research Coordinator B: communicate with a spectrum of stakeholders
• Clinical Research Coordinator B: help develop study process strategies
• Clinical Research Coordinator B: present data and reports to the research team

Clinical Research Coordinator A/B

• Advance AbbVie’s clinical research pipeline and help turn science into medicine for patients
• Serve as the primary point of contact for investigative sites
• Provide contextual information on clinical trials and connect stakeholders with investigative sites
• Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles
• Conduct site evaluation, training, routine, and closure monitoring in compliance with protocols, regulations, GCP, ICH Guidelines, SOPs, and quality standards
• Customize site engagement strategies and use CRM tools to track progress and measure impact
• Support day-to-day clinical trial execution by applying protocol, scientific, and clinical trial knowledge
• Evaluate recruitment and retention techniques based on the patient disease journey
• Mentor and train less experienced CRAs and contribute to their development
• Participate in global/local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team and address site risk signals
• Implement preventative and corrective action plans to mitigate risk and promote compliance
• Identify and evaluate potential investigators and clinical trial sites
• Ensure quality and timely submission of site data and safety-event reporting
• Maintain audit and regulatory inspection readiness
• Manage investigator payments where applicable

Clinical Research Associate II – Oncology

• Coordinate clinical trial management delivery
• Resolve clinical trial issues
• Develop team capability
• Oversee the clinical portion of the budget to ensure efficient resource allocation
• Develop monitoring plans and tools, ensuring effective study oversight
• Train and mentor Clinical Research Associates (CRAs)
• Drive enrollment and lead study start-up activities while adhering to timelines
• Review trip reports and implement corrective and preventative action plans when necessary
• Foster productive relationships with Sponsors, vendors, and cross-functional teams