Job DetailsJob Location: SIERTEK LTD - BEAVERCREEK, OH 45431Position Type: Full TimeSierTeK proudly serves our clients by providing expertise in the Program Management, Information Technology, and Administrative Support domains. Founded in 2007 as a minority and service-disabled veteran-owned company, we serve as prime- and subcontractor for a multitude of Federal Department of Defense contracts. By focusing on continual improvement, our services remain at the forefront of our industry, and we pride ourselves on delivering our services with the highest degree of integrity. SierTeK Ltd. is seeking a Statistical and Psychology Research Professional to support an opportunity remotely. Essential Job Functions • Assist in the development and execution of comprehensive study protocols, including hypothesis formulation, methodology design, data collection strategies, and statistical analysis plans, in coordination with USAFSAM/FESP professional staff. • Conduct scientific literature reviews and perform data analyses to support customer leadership; participate in technical discussions with USAFSAM/FESP staff. • Advise USAFSAM/FESP personnel on appropriate statistical methodologies and perform descriptive and inferential statistical analyses of study data. • Ensure the validity and integrity of statistical products and data repositories; maintain data security in accordance with IRB protocols and safeguards. Maintain confidentiality of sensitive data, reports, and findings, and complete all required IRB training and documentation. • Prepare scientific and technical reports to support publications, presentations, and other dissemination efforts in coordination with USAFSAM/FESP and 711 HPW staff. Deliverables will be based on the relevance and availability of research findings. • Provide professional support through travel, as required, for customer consultations, leadership briefings, and conference presentations. Coordinate travel expectations with USAFSAM/FESP personnel and maintain effective, secure communication with all stakeholders. • Manage project data, including acquisition, entry, maintenance, formatting, and storage. Support collection, maintenance, and integration of assessment data into project databases. • Provide project operations support, including assistance with USAFSAM/FESP research activities and data acquisition to meet project objectives. • Coordinate, facilitate, and participate in research team meetings, including leading a recurring weekly meeting to ensure effective communication and progress toward research goals. • Support additional USAFSAM/FESP research efforts, as required, during periods of reduced workload or interruptions in primary research activities. QualificationsMinimum Position Requirements • Master’s degree in Research Psychology, Industrial-Organizational Psychology, or a related field. • Minimum of 5 years of experience in database development, data collection and organization, statistical analysis, research reporting, and development of actionable recommendations to improve human performance. • Minimum of 5 years of experience designing and conducting statistical analyses using software such as JMP, SPSS, R, or equivalent. • Minimum of 5 years of experience developing and delivering research products, including professional presentations, peer-reviewed publications, and/or technical reports. • Minimum of 5 years of experience in administrative management related to study design, methodology, and dissemination of research findings. • Must have a signed Non-Disclosure Agreement (NDA) in place prior to start of performance, with documentation provided to the Government Program Manager. Highly Desired Qualifications • Doctoral degree, or Master’s degree with 7+ years of relevant experience, in Research Psychology, Industrial-Organizational Psychology, or a related field. • Experience conducting human performance or behavioral science research within a Department of Defense environment. • Experience developing and administering validated psychological assessments via mobile or web-based platforms. • Authorship or co-authorship of peer-reviewed journal articles or official USAF/DoD technical reports related to human performance or behavioral science research. • Certification in administering psychological assessments (e.g., NEO, Hogan, EQ-i) and providing individualized feedback. SierTeK is an equal opportunity employer. Employment is decided based on qualifications, merit, and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, gender identity and sexual orientation. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfer, leaves of absence, compensation, and training. If you need assistance or accommodation due to a disability, you may contact us at 1+833.743.7835.

• Conduct and oversee all types of site visits (e.g., selection, initiation, interim, close-out) to ensure protocol adherence, patient safety, and data accuracy. • Collaborate with Principal Investigators, study coordinators, and cross-functional teams to drive study success. • Ensure compliance with ICH/GCP, IRB requirements, and internal monitoring plans. • Identify and resolve data collection issues within electronic data capture (EDC) systems. • Review and reconcile data queries, listings, and discrepancies. • Maintain accurate and complete study documentation and files. • Lead study team meetings and contribute to protocol development and amendments. • Support site recruitment and provide oversight to ensure enrollment goals are met. • Mentor junior CRAs and provide technical expertise in clinical programming and data validation. • Assist in the development and refinement of SOPs, workflows, and templates. • Partner with Clinical Trials Manager to manage timelines, budgets, and resources. • Liaise with regulatory authorities and CROs as needed. • Ensure timely and compliant execution of monitoring reports, trip reports, and follow-up letters. • Monitor site performance metrics and facilitate effective communication across stakeholders.

• Oversee all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs • Conduct on-site and remote monitoring to ensure protocol adherence • Maintain essential documentation and keep site and patient data inspection-ready • Build strong relationships with sponsors and sites • Serve as a key point of contact throughout the study • Support development of study-specific procedures (e.g., Monitoring Plans) • Assist in training or coordinating other CRAs

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. • Demonstrates diligence in protecting the confidentiality of each subject/patient. • 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. •Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. • Conducts Source Document Review of appropriate site source documents and medical records. • Verifies required clinical data entered in the case report form (CRF) is accurate and complete. • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. • Verifies site compliance with electronic data capture requirements. • May perform 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. • 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. • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. • 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. • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. • Must be able to quickly adapt to changing priorities to achieve goals / targets. • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. • Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements • 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. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. • For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. • Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. • Knowledge of local requirements for real world late phase study designs. • Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. • The SMA II may be requested to train junior staff. • Identify and communicate out of scope activities to Lead CRA/Project Manager. • Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.