Clinical Operations

Clinical study is a costly, laborious, and time consuming process in the entire drug development procedure. Delivering a successful clinical study is dependent on multiple factors like clinical protocols, regulatory guidelines, industry standards, and best practices.

Stark Associates provides a full range of clinical operations services tailored to suit the unique needs and client requirements. Our robust strategies and efficient operational execution delivers rapid studies with quality expectations.

Clinical Operations Service Line:

Clinical Research Associate (CRA)
  • Monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols
  • Responsible for all Regulatory Documents, including Form 1572, Financial Disclosure, COI, GCP, Protocol, PI Credentials & and Study Personnel Qualifications
  • Perform study initiation activities, site visits, review protocols, study procedures, regulatory binder
  • Serve as a single point of contact (SPOC) between the pharmaceutical company (sponsor), and UTSW
  • Prepare IRB applications, including Protocol and Informed Consents, and obtain approval from IRB to conduct study. Ensure project is conducted according to UT Southwestern, and client’s SOPs
  • Ensure adherence to study protocol, GCP, Regulatory requirements. Maintained regulatory binder
  • Review Site selection, Coverage Analysis, and Budget, and seek approval from IRB
  • Review Clinical Trial Agreement (CTA), Start-up Binder, Essential Document Checklist
  • Responsible for the submission of Amendments, Informed Consent, Continuing Review, Advertising materials, protocol deviations / exceptions to IRB for approval
  • Maintain database of study subjects, reviewed Informed Consent Forms (ICF) and obtained subject ‘s consent, and HIPPA authorization
  • Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement
Clinical Trial Assistant (CTA)
  • Assist Clinical Research Associates (CRAs) and In-house Clinical Research Associate (iCRA) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
  • Collaborate with Clinical Project Manager (CPM), CRA and iCRAs on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files and completeness
  • Collaborate with CRA and iCRAs on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
  • Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
  • Assist in training and orienting new staff/mentoring less experienced CTAs
  • Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval
  • Perform assigned administrative tasks to support team members with clinical trial execution
  • Assist in monitoring visit preparations
  • Assist in reviewing medical records to ensure completeness and accuracy