Title: TI Senior Clinical Research Assistant Location: US-OR-Portland Requisition ID 2026-38920 Position Category Research Position Type Regular Full-Time Job Type Research Department Neurology Salary Range $24.43 - $40.72 per hour FTE 1.00 Schedule M-F Hours 8:00am - 4:30pm HR Mission School of Medicine Drug Testable Yes Job Description: Department Overview Therapeutic Intervention Senior Clinical Research Assistant position in the Parkinson Center and Movement Disorders Division, Department of Neurology. Responsible for coordinating multiple complex therapeutic interventional trials, with minimal supervision, while adhering to study protocol timelines and working closely with Principal Investigator to ensure participant safety. Provides leadership and training to junior staff through in-person training and shadowing, and development and maintenance of written materials. Independently prepares and submits regulatory packages to the IRB and assists Clinical Trials Manager with clinical trial start-up requirements and invoicing. Frequently collaborates with internal and external vendors and departments to arrange services required in the conduct of clinical trials. - Please include a cover letter with your application and resume. Function/Duties of Position Recruitment & Retention: recruitment of research volunteers by determining interest and eligibility in accordance with study protocol; explaining complex study design and procedures in lay language to potential participants; creating recruitment materials; screening and enrolling eligible participants, and retaining participants for duration of the study protocol. May also include attendance at and participation in community outreach events. Study Coordination: with minimal oversight, coordinate scheduling, preparation, and conduct of complex study visits involving multiple staff and hospital services; assure completion of study assessments and procedures per protocol; obtain informed consent; collect, process, store, and ship laboratory samples; conduct and/or assist with study procedures such as collection of vital signs, ECGs, lumbar punctures, & skin punch biopsies. Effective and professional communication (written / electronic and verbal) with study team, study participants, sponsors, contract research organizations (CRO), investigators, local and central Institutional Review Boards (IRBs), and other departments at OHSU. Preparation for and coordination of monitoring visits by CRO and federal agency representatives. Regulatory documents & submissions: ongoing maintenance of regulatory compliance and organization of all study documents and materials, adhering to Good Clinical Practice guidelines; independent preparation and submission of regulatory packages to local and central IRBs, including initial submissions, modifications, annual reviews, protocol deviations, and adverse event reports. Assist Clinical Trials Manager with clinical trial start-up, which may include site selection visits, IRB submissions, OnCore set-up, collaboration with internal and external vendors and departments, creation of case report forms, and other related tasks. Data Entry: timely, accurate completion of all required case report forms during study visits; entry of data into electronic data capture systems within sponsor-required timelines; timely resolution to data queries issued by sponsor and/or study monitor. Invoicing & Expenses: assist Clinical Trials Manager with tracking and reviewing study billing, including review of hospital charges and tracking invoiceable assessments and procedures. May also assist in preparation of invoices. Education & Support: in collaboration with the Clinical Trials Manager, lead and train junior staff through in-person instruction and shadowing, and develop and maintain written training materials. Monitor changes to university and industry standards for clinical trials compliance and share new information with the clinical trials team. Serve as trained, back-up study coordinator for several trials within the Movement Disorders Division, and other tasks as assigned. Communication: preparation for and participation in weekly meetings with the Clinical Trials Manager, including clinical research coordinator team and 1-on-1 meetings. Required Qualifications - Bachelor's Degree in relevant field AND 1 year of relevant experience, OR Associate's AND 3 years of relevant experience, OR 4 years of relevant experience, OR Equivalent combination of training and experience - Clinical research coordination experience, including conduct of multiple complex clinical trials and regulatory document maintenance, in role(s) with minimal oversight - Experience using electronic medical records system(s) - Independent IRB submissions (initial submissions, modifications, &/or annual review) - Clinical skills, such as phlebotomy, specimen processing, ECG, & vital signs measurements - Knowledge of clinical research regulatory standards and guidelines - Extremely well-organized with high attention to detail - Able to efficiently manage multiple tasks and demands with competing deadlines - A self-starter, able to work independently while being effective and efficient - Enjoys collaborating with and supporting colleagues in a team environment - Excellent written and verbal communication skills Preferred Qualifications - Experience using Epic medical record system - Familiarity with the procedures of the OHSU Institutional Review Board - Experience working with a senior population - Completed CITI (Collaborative Institutional Training Initiative) courses - Good Clinical Practice, Human Subjects Research, & Responsible Conduct of Research - SOCRA CCRP certification (Society of Clinical Research Associates Certified Clinical Research Professional) Additional Details Working Conditions: Primary work location is on campus, interacting with research participants and research study data. Occasional opportunities to work remotely. Working with human biological samples is required. In-person attendance at and participation in community events (approx. 6 per year), many of which occur on the weekend. Physical Demands: Ability to stand and walk throughout the OHSU campus for long periods of time during study visits. Why apply to OHSU? We are Oregon's only public academic health center. In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington. All are welcome. OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti-racist, multicultural institution and encourage people with diverse backgrounds to apply. To request reasonable accommodation, contact askhr@ohsu.edu

Role Description The Clinical Trial Manager (CTM) will provide clinical study support to the Clinical Program Manager/Study Management Team Lead (SMTL) for one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include: - Assuring successful conduct of clinical studies consistent with applicable regulations, guidelines, and procedures. - Supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring visits, meeting milestones and deliverables, and internal/external communications. This position is remote or in-house, depending on prior experience, and will report to a Clinical Operations Manager. Bay Area staff will operate in a hybrid or office-based model aligned with Arcus expectations. Responsibilities - Day-to-day management of assigned operational aspects of low to medium complex clinical trials, including vendor/laboratory management and oversight of clinical sites. - Obtains and reviews all required essential documents necessary for study/site initiation. - Maintains accurate and timely sponsor/site correspondence and communication. - Prepares and presents project progress reports. - Manages and tracks patient enrollment, site performance, and monitoring metrics. - Performs tasks in accordance with ICH GCP, regulations, the protocol, and company SOPs/Policies. - Supports the development and review of clinical study plans, presentations, or study-related documents. - Assists in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT on related systems. - Assists with set-up of central labs and study vendors as required, including liaising with Clinical Program Manager and CRO to ensure site training and timely initiation of clinical study sites. - Performs in-house review of clinical data listings for completeness and accuracy and escalates issues to the Clinical Program Manager, as needed. - Works closely with data management lead to perform data cleaning activities with cross-functional team. - May lead and coordinate protocol deviation review and documentation. - Manage clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics. - May perform accompanied site visits with CRO Site Monitors to ensure correct study procedures according to SOPs and protocol procedures. - Reviews monitoring trip reports and tracks resolution of all action items. - Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal). - Assists with providing oversight of CROs and vendors. - Coordinates with CRO and SMTL in clinical site oversight, data entry timeliness, and assists with resolving site issues. - Assists with set-up and review of clinical TMF. - Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings, as requested. - Contributes to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient-facing materials, etc. - Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable. - Recommends and implements innovative ideas to increase efficiency and quality of program management activities. - Contributes to process and departmental and cross-functional improvement activities. Qualifications - Bachelor’s degree, preferably in a scientific field. - 5+ years of related industry experience in the pharmaceutical industry or equivalent, plus 2+ years of trial management experience, preferably in oncology. - Demonstrates core understanding of clinical trial related terminology and activities. - Thorough understanding of ICH GCP guidelines and Code of Federal Regulations. - Understanding of clinical trial processes from study start-up through study closure. - Ability to establish priorities, sense of urgency, and collaborate with the study team, cross-functional team members, and external partners/vendors. - Excellent planning and organization skills. - Self-motivated, assertive, and able to function independently and as part of a team. - Strong interpersonal and negotiation skills as well as strong verbal and written communication skills. - Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e., EDC, IRT, CTMS, eTMF, etc.). - Ability and willingness to travel 10-20% (domestic and international). Company Description

Role Description We are sharing a specialised part-time consulting opportunity for physicians experienced in primary care, clinical documentation, patient case review, EHR data interpretation, clinical workflow analysis, and structured medical data validation. This role supports current and upcoming remote consulting opportunities focused on clinical data annotation, medical output validation, care pathway review, clinical workflow mapping, documentation standards, and high-quality project execution. Selected professionals will apply their physician expertise to review realistic patient cases, validate AI-generated clinical outputs, prepare structured feedback, and support accurate, evidence-based healthcare workflow tasks. Key Responsibilities - Clinical Data Annotation & Case Review - Review and annotate clinical text, EHR data, patient case notes, and medical documentation. - Identify diagnoses, co-morbidities, treatment plans, clinical outcomes, and relevant patient context. - Structure complex medical information for clinical reasoning, documentation, and workflow review. - Identify missing clinical context, documentation gaps, reasoning issues, and expected medical review outcomes. - Clinical Validation & Quality Assurance - Audit annotated datasets for clinical accuracy, consistency, and alignment with real-world medical practice. - Validate AI-generated summaries, recommendations, care pathways, and clinical reasoning outputs. - Evaluate outputs against standards of care, clinical guidelines, source documentation, and patient safety expectations. - Provide clear written explanations for clinical conclusions based on case facts and evidence-based criteria. - Medical Workflow, Guidelines & Feedback Support - Contribute to annotation guidelines, clinical taxonomies, decision frameworks, and documentation standards. - Define edge cases and nuanced clinical scenarios across primary care, inpatient, hospitalist, and general medicine workflows. - Evaluate AI systems designed to support clinical workflows, documentation, diagnosis, and treatment planning. - Provide structured feedback to improve clinical accuracy, safety, usability, and workflow alignment. Qualifications - MD or DO with experience in primary care, internal medicine, family medicine, hospital medicine, general medicine, or related clinical practice. - Board certification or board eligibility. - Active medical license in good standing. - 2+ years of clinical experience, with inpatient, hospitalist, or academic hospital experience helpful. - Strong familiarity with EHRs, clinical documentation, diagnoses, co-morbidities, treatment planning, and care pathways. - Clear written communication skills and strong attention to detail. Requirements - MD or DO degree is required. - Board certification, board eligibility, residency training, active licensure, academic hospital experience, teaching experience, or clinical leadership experience is highly relevant. - Background in primary care, internal medicine, family medicine, hospital medicine, or general clinical practice is especially relevant. Nice to Have - Experience reviewing EHR data, patient summaries, care plans, discharge notes, clinical documentation, or guideline-based recommendations. - Familiarity with clinical annotation, medical QA, informatics workflows, care pathway design, or healthcare data quality. - Experience at an academic hospital, large health system, primary care group, hospitalist service, or multidisciplinary care environment. - Interest in medical AI, clinical decision support, healthcare workflow design, or documentation improvement. - Strong comfort working through detailed, case-based, clinically nuanced review tasks. Benefits - Apply physician expertise to structured remote clinical review and healthcare data work. - Contribute to high-quality clinical validation, medical reasoning review, and healthcare workflow assessment. - Work on flexible assignments aligned with your medical background. - Use your clinical judgment in a focused, evidence-based medical review environment. - Remote structure with competitive hourly compensation. Contract Details - Independent contractor role. - Fully remote with flexible scheduling. - Part-time commitment depending on project availability. - Competitive rates between $120–$160 per hour depending on expertise. - Weekly payments via Stripe or Wise. - Projects may be extended, shortened, or adjusted depending on scope and performance. - Work will not involve access to confidential or proprietary information from any employer, client, or institution. About the Platform This opportunity is available through 24-MAG LLC. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.

Role Description The Clinical Trial Associate (“CTA”) is a highly skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and helping lead the study team across all investigator sites. Based on experience, the CTA assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The CTA may act as a Clinical Research Associate with limited monitoring responsibilities. Essential Job Functions and Responsibilities - Execute study activities according to study protocol, regulatory guidelines and operational plan. - Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures. - Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards. - Participate in study start-up, conduct, and closeout activities. - Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines. - Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes. - Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.). - Assemble and distribute regulatory binders to clinical sites. - Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs). - Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers. - Assist with preparation and distribution of investigator site contracts and budgets. - Schedule, set up, and minute study team and vendor meetings, as applicable. - Maintain metrics on results of study documentation reviews. - Support the review of invoices from vendors/consultants as needed. - Support the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT. - Support the planning of Investigator Meetings and/or Site and CRA trainings. - Manage the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples). - Maintain the Trial Master File for all clinical projects. - Perform periodic reviews and QC of the Trial Master File. - Travel as required to carry out responsibilities. - Other duties as assigned. Qualifications - Bachelor’s degree biological sciences or related discipline (an equivalent combination of experience and education may be considered). - Excellent written and verbal communication skills. - Strong PC skills (MS Word, MS Excel, MS Project). - Sound analytical and problem-solving skills. - Act with consistent sense of urgency with acute attention to detail. - Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred. - Exceptional organizational and time management skills. Physical Demands and Work Environment - On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. - Some walking and lifting up to 25 lbs. may be required. - The noise level in the work environment is typically low to moderate. - The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Travel - You may be required to travel for up to 5% of your time. Equal Opportunity Employer Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Vaccination Requirement Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation. Salary Range The salary range for this position is: $70,000 - $87,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.