Jake Hartley Email & Phone Number

South San Francisco, California, United States

Ophthalmology/Medical DevicesKey Achievements:- Managed data quality on a Phase III ophthalmology medical device trial (50+ study sites)- Led a study database migration based on a protocol amendment- Updated key study documents related to data cleaning and delivery- Coordinated data review and delivery for an FDA Safety Update Report- Developed skills.

• Oncology/OphthalmologyKey Achievements:
• Adopted Agile methodology with a team of 4 overseeing more than 800 sites across 8 ophthalmology studies and 1 oncology study
• Developed data streams using Google Apps Script to provide up-to-date, centralized study information resulting in less time pulling reports and searching for relevant data
• Fostered close working relationships with global clinical management teams and encouraged study-wide collaboration like the development of websites to assist CRAs in site monitoring
• Assisted with inspection preparation for the FDA, EMA, MOHW, and PMDA, speaking on behalf of the sponsor in health authority interviews and providing time-sensitive assistance during site inspections
• Organized a monthly meeting across different study teams to share processes and scripts with a focus on automating repetitive, error-prone study tasks

Palo Alto, California, United States

• Research Focus: Depression and Mechanistic Trials
• Provide compliance oversight in accordance with ICH GCP guidelines across four active NIH and privately funded studies with total recruitment goals approaching 400 participants.
• Led a shift to clinical research involving prescription medication and investigational products, overseeing the ramp-up from one active study with clinical trial designation to four.
• Created and implemented a framework for study start up to ensure standardized data collection, research organization, and study feasibility.
• Experience with Institutional Review Board submissions, research protocol drafting, NIH reports, Research Advisory Panel of California applications, and Investigational New Drug applications.
• Familiar with Schedule I-III drug regulations for research studies.

Palo Alto, California

• Research Focus on Primary Headache Clinical Trials:
• Independently managed 9 industry-sponsored trials in drugs, biologics, devices and implants
• Worked to streamline communication between key study groups to improve workflow, resulting in faster study start up
• Experience in TMF management and EDC system data entry and query resolution.
• Simultaneously managed new study start-up, budget, IRB submissions, protocol implementation, and subject recruitment/retention
• Acted as a liaison between contracted study monitors and pharmaceutical companies to ensure studies were conducted properly and according to protocol

Madrid Area, Spain

• Assistant English Teacher at a primary school in the community of Madrid.
• Taught students between the ages of 8 - 12 English writing, speaking, and listening comprehension
• Led classes of up to 25 students
• Prepared lesson plans and testing materials to prep students for English proficiency exams
• Fostered conversation around culture and life in the US and Spain
• Developed a working proficiency in the Spanish language equivalent to that of a B2 level (CEF Level)

Palo Alto, California

• Primary Research Objective: To develop an understanding of attentional deficits that occur after concussion.
• Trained in the administration of study specific neuropsychological testing batteries given to subjects between 8 and 70 years of age for testing sessions 30 minutes to 2 hours long.
• Interacted with parents of pediatric subjects in the case of study specific questions or concerns.
• Assisted in the preparation of multi-hour, off-site study testing session by anticipating needs and potential problems.
• Organized the of follow up patient encounters.
• Worked in a clinical setting at the Stanford Neurosciences Building Concussion Clinic to deliver experimental diagnostic concussion testing.

Stanford University, Stanford, California

• Stanford Vision Perception and Neurosciences LabPrimary Research Objective: To observe the neurological function of the fusiform face area in children as compared to adults, and determine correlates in perceptual.
• Assisted with experimental design and test implementation. Certified to assist with the administration of fMRI scans of test subjects.
• Worked extensively with Adobe Photoshop and face-morph software (Morph Age Pro) to create clean, study specific stimuli for fMRI subject testing.
• Assisted in the recruitment of study subjects.
• Co-author on a scientific publication. Listed on 2 abstracts.

Stanford University

• Stanford Varsity Men's Swimming Team member.
• Committed 20 hours per week, not including swimming competitions while in season.
• Developed exceptional time management skills and an appreciation for team camaraderie and commitment.

Palo Alto, California

• Contributed to Stanford University fundraising efforts by contacting recent alumni and asking for donations.
• Strengthened communication skills and verbal flexibility.