Role Description This research assistant will support investigators in various research-related activities, providing essential assistance while gaining valuable training experience. This research project investigates social determinants of prenatal substance use in American Indian communities. This position can be remote but must be within the area of the Spirit Lake communities. Duties & Responsibilities - Assist with participant recruitment, community outreach and preparation of recruitment materials - Support participant orientation sessions - Coordinate and support data collection activities, including interviews and focus groups - Support qualitative data analysis - Maintain organized research documentation - Assist with literature reviews - Travel to Spirit Lake community sites for data collection & photo exhibitions - Attend meetings with PI and other colleagues, as needed Qualifications - Associate's degree (AA/AS) or higher in social work, psychology, public health, criminal justice, education, human services or a related field - Currently enrolled in one of these programs - High school diploma/GED with at least one year of relevant work or community experience in research, community engagement, health promotion or human services in the Spirit Lake communities - Ability to travel to research site - Successful completion of a Criminal History Background Check - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the US and to complete the required employment eligibility verification form upon hire - This position does not support visa sponsorship for continued employment Preferred Qualifications - Experience with qualitative research methods - Experience volunteering for, living in, or working with American Indian communities - Cultural humility - Commitment to community-engaged research To Apply Please submit a cover letter and resume/CV.

• Responsible for managing study sites in studies overseen by Medical Operations • Ensure that all activities are conducted in accordance with relevant processes, procedures, and applicable local laws and regulations • Support timely and high-quality delivery of data • Play a key part in the planning, coordination, oversight, and delivery of clinical study activities • Work closely with the Medical Operations Manager and cross-functional stakeholders

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Updates, tracks and maintains study specific trial management tools/systems, and status reports. • If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. • Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. • Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. • Performs investigation product (IP) inventory, reconciliation and reviews storage and security. • Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Updates, tracks and maintains study specific trial management tools/systems, and status reports. • If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. • If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. • Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. • Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. • Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. • Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. • Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process. • Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team. • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. • Travels as necessary according to project needs. • Performs other duties as assigned by management.