Kirstin Graham, RN BSN CCRA
Wayne,PA
Summary
Accomplished Senior Clinical Research Associate with over 20 years of extensive experience in clinical trial monitoring across diverse therapeutic areas, including CNS, Infectious Disease, Oncology, and Rare Diseases. Proven expertise in site compliance and regulatory adherence drives the successful execution of complex studies. A strong focus on enhancing site performance through effective communication, training, and strategic oversight consistently yields exceptional results. A steadfast commitment to data integrity and proactive issue resolution supports the management of both blinded and unblinded study teams, achieving outstanding performance metrics. Dedicated to fostering collaboration that aligns with organizational objectives and ensures successful trial outcomes, with a track record of leading turnaround efforts at high-risk or non-compliant study sites.
Overview
32
32
years of professional experience
Work History
Senior Clinical Research Associate
Worldwide Clinical Trials
07.2025 - Current
- Directed cross-functional teams by assigning tasks, developing project schedules, and allocating resources to ensure timely achievement of study objectives.
- Mitigated risks to subject safety and study integrity by proactively identifying site-level issues and implementing corrective actions during monitoring visits.
- Demonstrated strong self-motivation and personal accountability in managing complex clinical operations.
- Collaborated effectively within multidisciplinary teams while maintaining the ability to work independently in high-pressure environments.
- Adapted quickly to evolving protocols and regulatory requirements, consistently delivering high-quality results.
- Enhanced trial efficiency by streamlining data collection and management workflows, reducing delays and improving data accuracy.
- Stabilized study conduct and reinforced GCP compliance following suboptimal CRA oversight, ensuring protocol adherence and regulatory alignment.
- Managed 12 high-enrolling clinical sites across two priority studies, ensuring consistent performance and protocol adherence.
Contract Senior CRA
Duke Clinical Research Institute
09.2022 - 07.2025
- Led monitoring strategies for clinical trials research at Duke University and Affiliates.
- Worked effectively in fast-paced environments.
- Managed time efficiently in order to complete all tasks within deadlines.
- Created tools and procedures for trial monitoring, identifying and executing site visits.
- Collaborated with cross-functions teams to exceed enrollment and retention goals
- Performed site assessments and monitoring visits independently according to protocols.
- Managed monitoring activities for complex, rare disease, NIH-sponsored trials.
- .5 - 1 FTE
- Self-motivated, with a strong sense of personal responsibility.
Contract Senior CRA
Everest Clinical Research
10.2017 - 07.2025
- Collaborated with study Sponsors, sites, vendors, and functional groups to facilitate clinical trial initiations and completions.
- Worked well in a team setting, providing support and guidance.
- Self-motivated, with a strong sense of personal responsibility.
- Ensured site compliance with ICH-GCP and local regulations.
- Developed and implemented tool for gap analysis qualification documentation and assist with regulatory document submissions.
- Reviewed and developed Informed Consent Forms and conduct on-site monitoring for clinical trials.
- Led CRA team for Multi center, Multi-arm Multiple Myeloma Trial
- .5-1 FTE
Senior Site Manager, Lead CRA
ExecuPharm, Inc
01.2014 - 09.2022
- Monitored investigator sites with a risk-based approach
- Developed detailed project schedules, ensuring timely completion of milestones and adjusting resources as needed.
- Applied root cause analysis to identify and address site issues as a member of the CAPA team
- Documented observations and communicated deficiencies promptly
- Collaborated with cross-functional teams (clinical operations, data management, safety , and regulatory) to ensure high-quality trial execution.
- 1 FTE on assignment with various CROs conducting industry-sponsored trials (Phases I-IV) across multiple therapeutic areas.
- Therapeutic areas covered include cardiology, CNS, dermatology, endocrinology, infectious diseases, nephrology, oncology, ophthalmology, pulmonary, surgery, uveitis, vaccine.
- Demonstrated adaptability working across multiple CRO platforms, SOPs and sponsor-specific systems.
Senior Clinical Research Associate
IQVIA
10.2020 - 08.2021
- Emergency Pfizer COVID 19 Trial
- Provided support to clinical research teams throughout the drug development process
- .25 FTE
Senior Site Manager
Aerotek
10.2020 - 08.2021
- Home-based
- Documented monitoring activities and submit reports to Clinical Operations management
- Managed sites by providing direction, assessing performance, and proposing interventions
- Communicated directly with investigational sites to enhance enrollment performance
- Reported progress and status of investigational sites to ensure study success.
Senior Site Manager
RPS, Inc
04.2011 - 01.2014
- Independently managed full-site monitoring responsibilities including site initiation, routine monitoring, and close-out visits for global and regional trials.
- Built and maintained strong professional relationships with principle investigators and study coordinators, fostering site engagement, compliance, and retention.
- Served as a key point of contact between sponsor and site personnel, resolving site-level issues efficiently and proactively.
Field Clinical Monitor
KForce Clinical Research, Inc
10.2008 - 04.2011
- Led day-to-day support for study operations, tracking subject, site, study status, and milestones.
- Conducted oversight on clinical monitoring activities to ensure data integrity.
- Assisted in study set-up, including Case Report Form design, protocol review, and investigator selection.
- Processed clinical trial materials requests, safety letters, and study-related supply requests.
- Collaborated with cross-functional team members to ensure compliance with FDA regulations and SOPs.
Lead Lead Clinical Research Associate
i3 Research
04.2003 - 10.2008
- Scheduled and conducted pre-study site visits efficiently.
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
- Submitted routine monitoring trip reports and follow-up letters to facilitate internal and external communication.
- Conducted essential document retrieval and developed monitoring guidelines.
- Assisted in patient enrollment strategy and created monitoring tools.
- Developed CRFs, managed site assignments, and conducted training sessions.
- Reviewed trip reports, resolved queries, and provided close-out guidelines.
- Liaised between sponsors, CROs, and vendors
- FTE
Regional Clinical Research Associate II
AAI International
08.1999 - 04.2003
- Conducted routine site visits for pre-study, initiation, interim, and close-out phases.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Facilitated communication between Investigators, project team, and Sponsoring company.
- Oversaw study process from initiation to close-out.
- Recruited Investigators and trained new Monitors.
- Reviewed reports, provided feedback, reported adverse events, and completed documentation accurately.
HIV Research Nurse
Massachusetts General Hospital/Harvard Medical School
07.1998 - 08.1999
- Coordinated and conducted clinical trials related to HIV research.
- Collaborated with multidisciplinary teams to analyze and interpret data.
- Provided patient education and support throughout clinical trials.
- Communicated trial findings and progress to healthcare professionals and patients.
Medical/Surgical Nurse
Favorite Nurses Incorporated
01.1998 - 12.1998
- Provided direct patient care in a medical/surgical setting
- Administered medications and treatments as prescribed by healthcare providers
- Monitored and assessed patients' conditions, updating medical records accordingly
- Collaborated with interdisciplinary healthcare team to ensure optimal patient outcomes
- Participated in patient and family education regarding treatment plans and discharge instructions.
- Educated patients and families on medical-surgical procedures, therapeutic regimens, and pain management techniques.
- Monitored patients before, during and after surgical operations to evaluate patient care.
- Efficiently managed complex caseloads of diverse patient populations while maintaining attention to detail in documentation.
Clinical Research Nurse
Hebrew Rehabilitation Center for the Aged/Harvard Medical School
12.1997 - 07.1998
- Coordinated and conducted clinical research studies with precision and attention to detail
- Collaborated closely with interdisciplinary team members to ensure study protocols are followed
- Communicated effectively with study participants and their families to provide guidance and support
- Maintained accurate and thorough documentation of study procedures and participant data
- Adhered to ethical guidelines and regulatory requirements in all research activities
- Served as a liaison between the research team and participating sites, fostering effective communication and collaboration among all parties involved in the study.
Charge Nurse
Fair Acres
01.1995 - 12.1997
- Managed a 43-bed Nursing Unit for young adults with chronic illnesses.
- Promoted a safe working environment by adhering to infection control policies and regularly reviewing safety protocols.
- Trained new nurses in proper techniques, care standards, operational procedures, and safety protocols.
- Supervised Registered Nurses, Licensed Practical Nurses, and Certified Nursing Assistants in daily patient care.
- Coordinated care plans and treatment for residents.
- Directed team in providing intermediate, heavy, and skilled care.
- Ensured quality care and adherence to protocols.
Clinical Research Associate I
BioPharm Clinical Services
01.1994 - 12.1994
- Oversaw clinical trial activities, ensuring compliance with protocols and regulations.
- Conducted site visits to monitor data quality and participant safety.
- Collaborated with investigators and site staff to resolve study-related issues.
- Assisted in preparing reports and documentation for regulatory submissions.
- Tracked study progress and maintain accurate study files.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Conducted thorough site feasibility assessments for potential clinical trial participation, identifying suitable sites for studies.
Education
Bachelor of Science - Nursing
Villanova University
Villanova05-1994
Skills
- Certified Clinical Research Associate
- Regulatory Compliance
- Data quality assurance
- CAPA implementation expertise
- Employee training
- Problem-solving expertise
- Enrollment optimization
- Study Start up
- Skilled in resolving conflicts
- Report reviewer
- Team leadership qualities
- Proficient in Microsoft Excel, Word, and PowerPoint
- Clinical trial management systems expertise
- Informed consent process
Websites
Therapeutic Areas
Cardiovascular
- ASCVD (phase III)
- Device/PCU stent
- Hypertension (phase III)
- Stroke (phase II/ESUS)
Central Nervous System
- ALS (Observational)
- Alzheimer (phase III)
- Angelman Syndrome
- Attenuated Psychosis Syndrome (phase II, III)
- Seizure
- Major Depressive Disorder (phase II, III)
- Neonatal Opioid Withdrawal Syndrome (NIH)
- Schizophrenia (phase II)
Musculoskeletal
- Osteoarthritis (phase III)
- Rheumatoid Arthritis (phase I–IV)
- Psoriatic Arthritis
- Scleroderma (phase I–II)
Pain Management
- Pain (phase III) – Unblinded CRA
Dermatology
- ED-based Urticaria (phase II)
- Herpes Zoster
- Squamous Cell Carcinoma
Endocrinology
- Diabetes (phase II, III, III-b)
Gastrointestinal
- Irritable Bowel Syndrome (phase III)
- SGVHD (phase IIa)
Infectious Disease
- Hepatitis C (phases II, III, IV)
- HIV (phases I, II, III, IV)
- Influenza (phases II, III, IV)
- Coronavirus
Drug Delivery & Transplant
- Nasal Drug Delivery Device
- Stem Cell Transplant
Nephrology
- Acute Kidney Injury (phase II)
- ESRD (phase III)
- Dialysis Treatment (phases III, IV)
Ophthalmology
- Diabetic Retinopathy (phase IIa)
- Macular Degeneration (phase I)
- Uveitis (phase II)
Otolaryngology
- Allergy (phase IV)
Oncology
- Multiple Myeloma (phase I/II)
- Small Cell Lung Cancer (phase III)
- Chronic Lymphocytic Leukemia (CLL) (phase II)
- HER2-negative Breast Cancer (phase II)
- Chronic Lymphocytic Leukemia
- Ovarian Cancer (phase II)
Pulmonary
- Chronic Obstructive Pulmonary Disease (phases III, IV)
- Interstitial Lung Disease (phase I)
Surgery
- Device/Surgical Glue
Timeline
Senior Clinical Research Associate
Worldwide Clinical Trials
07.2025 - Current
Contract Senior CRA
Duke Clinical Research Institute
09.2022 - 07.2025
Senior Clinical Research Associate
IQVIA
10.2020 - 08.2021
Senior Site Manager
Aerotek
10.2020 - 08.2021
Contract Senior CRA
Everest Clinical Research
10.2017 - 07.2025
Senior Site Manager, Lead CRA
ExecuPharm, Inc
01.2014 - 09.2022
Senior Site Manager
RPS, Inc
04.2011 - 01.2014
Field Clinical Monitor
KForce Clinical Research, Inc
10.2008 - 04.2011
Lead Lead Clinical Research Associate
i3 Research
04.2003 - 10.2008
Regional Clinical Research Associate II
AAI International
08.1999 - 04.2003
HIV Research Nurse
Massachusetts General Hospital/Harvard Medical School
07.1998 - 08.1999
Medical/Surgical Nurse
Favorite Nurses Incorporated
01.1998 - 12.1998
Clinical Research Nurse
Hebrew Rehabilitation Center for the Aged/Harvard Medical School
12.1997 - 07.1998
Charge Nurse
Fair Acres
01.1995 - 12.1997
Clinical Research Associate I
BioPharm Clinical Services
01.1994 - 12.1994
Bachelor of Science - Nursing
Villanova University