Clinical Monitoring & Consultation

Company: TechWerks
Location: Silver Spring
Posted on: November 12, 2021

Job Description:

TechWerks LLC (TechWerks) is a rapidly growing company that has been supporting the VA and DOD for over 11 years. With over 200 employees and annual revenue of 15-20 million, TechWerks is a proven company with a highly respected leadership team consisting of career military veterans dedicated and committed to supporting the military and veteran communities. TechWerks specializes in healthcare information technology, training, analytics, and clinical research. This scientific service will support the Center for Military Psychiatry and Neuroscience---s research programs. The mission of the Center for Military Psychiatry and Neuroscience is to conduct basic and applied research that promotes psychological resilience, neurological functioning, and operational readiness in Service Members and to develop evidence-based strategies to diagnose, prevent, and mitigate the effects of psychological demands, continuous operations, and brain trauma on the health and well-being of Service Members. The consultants will support the overall goal of developing evidence- based strategies to diagnose, prevent, and mitigate the effects of psychological consequences of combat deployments. PRINCIPAL DUTIES AND RESPONSIBILITIES: Consultant shall perform clinical site monitoring as requested, to assess compliance with the approved protocol, contractual agreement, and CFRs to ensure protocol and regulatory compliance. Scope of clinical site monitoring will include, but not be limited to the following activities: Ensure compliance with local, state, and federal regulations, to include, but not limited to, local and institutional policies and procedures, FDA, ICH, NIH Guidelines, and HIPAA, as applicable. Drafting and finalizing study-specific clinical monitoring plans Site qualification visits Initiation visits prior to the start of enrollment Review of Essential Documents as part of the initiation visit Clinical monitoring of enrolled subjects. Drafting and provision of clinical monitoring reports Close-out visit Drafting and provision of study-specific closeout monitoring report Source verification of study data Monitoring performed according to good clinical practice (GCP) and TechWerks standard operating procedures. Site contact and follow-up for the assessment of subject recruitment, retention, and compliance. Utilization of clinical data management system (CDMS) to perform monitoring of eCRFs. Protocol development and clinical trials material development, as requested Training, as needed. These assumptions may vary based on Customer/Contract need. MINIMUM QUALIFICATIONS: BA or BS degree in Life Science/health related field required, Master's degree is preferred 5+ years--- experience as a Clinical Research Associate Certified as a CRA, e.g. CCRA , CCRP, or other CRA certification required Familiarity with monitoring processes in paper and/or eDC environments. GENERAL INFORMATION: The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required. The employee must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek supervisory assistance as appropriate

Keywords: TechWerks, Silver Spring , Clinical Monitoring & Consultation, Healthcare , Silver Spring, Maryland