Job Description

ASRC Federal is a leading government contractor furthering missions in space, public health and defense. As an Alaska Native owned corporation, our work helps secure an enduring future for our shareholders. Join our team and discover why we are a top veteran employer and Certified Great Place to Work ASRC Federal is seeking a Clinical Research Associate with experience in site initiation, site monitoring and site close-out visits for clinical studies. Join our growing team and let's defeat cancer in our lifetime. **Responsibilities** + Monitor clinical studies and investigational sites for adherence to study protocols, GCP/ICH guidelines, and company SOPs. + Prepare and conduct Site Initiation Visits (SIV), routine Site Monitoring Visits (SMV), and Site Closeout Visits (SCV) for assigned studies. + Review clinical study documents, including Informed Consent Forms (ICF), source documents, patient instruction guides, and Case Report Forms (CRFs). + Assist in identifying investigational sites and perform site qualification visits as needed. + Monitor clinical study progress and prepare progress reports for investigators (e.g., patient accrual, audit findings, data transmission, and reporting activities). + Ensure data quality from clinical sites and assist in resolving patient eligibility issues and protocol deviations. + Serve as a liaison and resource for assigned investigational sites. + Analyze monitoring findings, identify trends, and provide recommendations for process improvements to management. **Requirements** + Bachelor's degree in a Life Science, Biological Science or other related medical degree and 3+ years of related work experience. + Experience in conducting site initiation visits, monitoring visits and close-out visits required. + Quality assurance or experience in finding "gaps" in processes so training and "best practices" , SOPs can be initiated is a plus. + Working knowledge of clinical research processes, regulatory requirements, data collection requirements and methodologies. + Knowledge of Good Clinical Practices/ICH and SOPs + SoCRA or ACRP certifications are desirable as is a Master's degree in a Life Science, Biological Science or related Medical field + Ability to obtain a Public Trust clearance We invest in the lives of our employees, both in and out of the workplace, by providing competitive pay and benefits packages. Benefits offered may include health care, dental, vision, life insurance; 401(k); education assistance; paid time off including PTO, holidays, and any other paid leave required by law. **_EEO Statement_** _ASRC Federal and its Subsidiaries are Equal Opportunity employers. All qualified applicants will receive consideration for employment without regard to race, gender, color, age, sexual orientation, gender identification, national origin, religion, marital status, ancestry, citizenship, disability, protected veteran status, or any other factor prohibited by applicable law._ **Job Details** **Job Family** **Health & Life Sciences** **Job Function** **Healthcare Analyst** **Pay Type** **Salary**

Job Tags

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