In-House Clinical Research Associate

SUMMARY

Supports the planning, execution, and oversight of clinical studies at assigned study sites. Responsible for supporting site activation, protocol compliance, regulatory documentation, and study closeout activities in alignment with Good Clinical Practices (GCP), applicable regulatory standards, and company SOPs. Works closely with Site Management teams to ensure timely and accurate study execution.

RESPONSIBILITIES

Clinical Study & Site Support Support regulatory and clinical protocol compliance across assigned clinical projects. Coordinate study start-up, maintenance, and closeout activities with field staff and internal teams. Act as a primary point of contact for assigned study sites. Assist with study site activation and ongoing site management activities. Support training of external clinical professionals on study protocols and compliance requirements. Regulatory & Documentation Management Collect, review, and maintain essential regulatory documents. Review informed consent forms to ensure required elements are included. Maintain and update internal clinical trial systems and Trial Master Files (TMF). Facilitate study site communication and documentation throughout the study lifecycle. Data Review & Compliance Review and analyze study data and regulatory documentation for accuracy and completeness. Assist with resolving data queries, missing information, and protocol deviations. Support follow-up and resolution of findings from monitoring visits and audits. Perform site compliance reviews under supervision and lift issues when necessary. Communication & Collaboration Serve as a liaison between study management, site personnel, vendors, and internal stakeholders. Communicate effectively with employees, customers, contractors, and vendors at all levels. Support process improvement initiatives at the regional or global level.

QUALIFICATIONS

Bachelor’s degree preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering with a minimum of two years of experience, or an equivalent combination of education and experience Must have strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees. Must be proficient in Microsoft Office Suite. Able to work independently, seeking guidance when necessary.

PREFERRED

A general familiarity with clinical trials research processes. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment. Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP). #J-18808-Ljbffr GForce Life Sciences