Christine Streaker
Easton,MD
Summary
Accomplished Clinical Research Consultant with extensive experience. Expert in operations management and strategic partnerships, driving project success and enhancing team productivity. Proven track record in developing SOPs and improving data quality, leveraging strong leadership and project management skills to achieve organizational goals.
Overview
30
30
years of professional experience
Work History
Co-Founder and Clinical Research Consultant
Constellation Clinical Research
08.2023 - Current
- Project and Site Management
- Policy and Standard of Practice (SOP) Development
- Clinical Research Training
- Senior Management/Oversight
- Vendor Review and Selection
- Recruiting
- Study Plans
Quality Assurance Consultant
EnLiven Therapeutics
02.2024 - 08.2024
- Performed Gap Analysis on current SOPs/Templates/Forms
- Wrote companywide Standard Operating Procedures (SOPs)
- Responsible for companywide training metrics
- Reviewed/Edited Templates/Forms/Work Instructions
Senior Clinical Technical Writer
ImPact Biotech
08.2023 - 02.2024
- Proved successful working within tight deadlines and a fast-paced environment.
- Merged SOPs being used into new SOPs (CRO and Biotech)
- Developed Project Plans
- Managed version control and timely updates of documents through effective project tracking and organization skills.
- Conducted thorough document reviews to identify inaccuracies, inconsistencies, or areas needing clarification.
- Followed company policies and editorial guidelines to craft thorough, well-written content.
Senior Clinical Trial Manager
SymBio Pharmaceuticals
08.2022 - 08.2023
- Assisted in building infrastructure for US component of company
- Developed all Clinical Operations SOPs, Work Instructions and Training
- International work with vendors and sites: Japan, South Korea, Australia, China and Thailand
- Designed Feasibilities and Investigator Database Questionnaires
- Created Investigator Database to improve site selection, feasibility, and study start-up efficiency
- Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
- Facilitated clear communication between study teams, CRO, and investigators to maintain alignment on project goals and expectations.
- Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial.
Senior Manager
Chiltern International
11.2010 - 04.2017
- Managed teams of CTAs, CRAs, Senior CRAs, Managers, Lead CRAs
- Provided strong leadership to enhance team productivity and morale
- Led cross-functional teams to achieve project milestones and deliver high-quality results
- Improved team performance by providing comprehensive training and fostering a collaborative work environment
- Completed formal performance reviews for direct reports
- Worked in conjunction with HR on hiring/terminating
- Ensured direct reports were managed by review of allocation, working hours, progress of objectives set
- Mentored junior staff members for skill development and career progression within the organization.
- Reviewed and analyzed reports, records and directives to obtain data required for planning department activities.
- Responsible for core department functions such as salary review, bonus awards, sign off visits and promotion decisions
Global Clinical Project Manager
PRA International
09.2007 - 11.2010
- Managed and led clinical operations activities for clients and global clinical research projects
- Primary point of contact for sponsor, project management and senior management on assigned trials
- Led clinical operations team by providing study specific and therapeutic training and mentoring
- Oversaw contract negotiation and vendor selection for clinical projects, securing cost-effective solutions without compromising quality or timelines.
- Collaborated closely with medical experts, investigators, and external partners to ensure accurate data collection in line with research objectives.
- Managed cross-functional teams, resulting in seamless collaboration and increased productivity in clinical projects.
- Reduced project timelines for successful clinical trials by effectively managing resources and maintaining clear communication with stakeholders.
Manager-Clinical Operations
Pfizer/KForce
08.2005 - 06.2007
- Managed 13-18 direct reports
- Recruited, interviewed, and selected candidates to fill open positions across multiple departments
- Led full-cycle recruitment, including sourcing
- Founded "TDS"- Territory Development Specialist Role and oversaw position
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Maximized performance by monitoring daily activities and mentoring team members.
- Cross-trained existing employees to maximize team agility and performance.
- Developed a strong company culture focused on employee engagement, collaboration, and continuous learning opportunities.
Monitoring Process Trainer
Pfizer/KForce
08.2003 - 07.2005
- Delivered robust training courses via classroom and e-learning programs.
- Leveraged industry best practices when developing curriculum content, ensuring that employees remained up-to-date on key trends.
- Managed scheduling logistics for all training sessions, ensuring minimal disruption to day-to-day operations.
- Developed comprehensive training materials, resulting in improved overall performance among trainees.
Lead Clinical Research Associate
MDS Pharma Services
09.1999 - 07.2003
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
Clinical Research Coordinator
Clinical Studies, Inc
09.1997 - 08.1999
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Senior Clinical Research Coordinator
University of Pittsburgh; Dept Otolaryngology
12.1995 - 08.1997
- Contributed to the successful completion of numerous studies by coordinating all aspects of trial initiation, execution, and close-out activities.
- Enhanced data quality by closely monitoring study metrics and resolving discrepancies in a timely manner.
- Optimized patient safety during clinical trials by diligently monitoring adverse events and promptly escalating concerns when necessary.
- Collaborated with investigators to develop innovative clinical trial designs, optimizing data collection methods for better results.
Education
Biology/Chemistry
Carlow University
Pittsburgh, PASkills
- Business development
- Strategic partnerships
- Strategic visioning
- Customer relations
- Operations management
- Staff management
- Customer relationship management
- Project management
Accomplishments
Active Member of SOCRA and ACRP
PharmaTimes Semi-Finalist
Completed Dale Carnegie Training for Management
Developed and Executed "ITP"-Investigator Training Program
Developed and Executed Line Manager Training Program
Timeline
Quality Assurance Consultant
EnLiven Therapeutics
02.2024 - 08.2024
Co-Founder and Clinical Research Consultant
Constellation Clinical Research
08.2023 - Current
Senior Clinical Technical Writer
ImPact Biotech
08.2023 - 02.2024
Senior Clinical Trial Manager
SymBio Pharmaceuticals
08.2022 - 08.2023
Senior Manager
Chiltern International
11.2010 - 04.2017
Global Clinical Project Manager
PRA International
09.2007 - 11.2010
Manager-Clinical Operations
Pfizer/KForce
08.2005 - 06.2007
Monitoring Process Trainer
Pfizer/KForce
08.2003 - 07.2005
Lead Clinical Research Associate
MDS Pharma Services
09.1999 - 07.2003
Clinical Research Coordinator
Clinical Studies, Inc
09.1997 - 08.1999
Senior Clinical Research Coordinator
University of Pittsburgh; Dept Otolaryngology
12.1995 - 08.1997
Biology/Chemistry
Carlow University
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