Jake Hartley Email & Phone Number

San Francisco, Ca, Us

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 related to database builds, electronic case report form guideline development, and query management

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• Developed websites for Clinical Research Associates to more effectively disseminate study information and guidelines, effectively reducing email workload study team members

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.• Lead a team of research staff to conduct complex longitudinal studies involving prescription intervention.• Proactively communicate with a team of doctors, pharmacists, and scientists to manage study subject safety, regulatory requirements, and data analysis.

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• Led a workgroup initiative resulting in the restructuring of new-hire onboarding allowing for smoother transition into the coordinator position and a healthier team culture

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. • Developed lab and site relations to ensure protocol adherence and timely follow up of patient study visits. • Consented, tested and followed up on 100+ study subjects (email, phone, in-person)• Designed and built a clinical database using REDCap, an electronic data capture software. • Personally worked on and was listed as a collaborator on 5 abstracts presented at 7 conferences.

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 discriminability. •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.