Clinical Research Assistant

JOB SUMMARY

A Clinical Research Assistant is an entry-level research position. This position is responsible for performing a variety of duties including coordinating aspects of clinical trial protocols including but not limited to study initiation, recruitment, study visits, monitor visits, regulatory compliance, study close-out, along with but not limited to other administrative tasks.

KEY RESPONSIBILITIES

Patient Care & Study Visits

• Obtain informed consent (when delegated) while ensuring compliance with ethical and regulatory requirements

• Screen prospective participants for eligibility in non-interventional (Non-IP) clinical studies in accordance with study protocols and inclusion/exclusion criteria.

• Provide patient care and collect, document and maintain accurate medical and research data during study visits in compliance with study protocols and regulatory requirements.

• Instruct patients regarding study protocols and visit requirements.

• Arrange for or perform phlebotomy and other delegated clinical procedures.

• Pack and ship laboratory specimens and collect laboratory results.

Participant Recruitment and Screening

• Identify potential research participants through medical records, referrals, databases, provider referrals, and community outreach.

• Conduct thorough remote pre-screenings and eligibility assessments, coordinating with healthcare professionals as needed to verify medical history and suitability.

• Perform initial outreach to pre-identified research participants to discuss study opportunity

• Schedule research appointments and coordinate participant visits. Appropriate documentation within the Innovo specific CTMS system as trained.

Study Coordination & Documentation

• Maintain accurate case report forms (CRFs), source documents, and study records.

• Maintain regulatory documentation in accordance with sponsors, FDA, GCP, and protocol requirements.

• Document patient interactions, recruitment activities, and enrollment efforts accurately and in timely within the Innovo specific CTMS system as trained.

• Maintain study supplies and inventory necessary to support research activities.

Collaboration & Communication

• Serve as a liaison between investigators, providers, sponsors, patients, and study representatives.

• Collaborate with Clinical Research Coordinators, investigators, healthcare providers, and administrative staff to support study execution.

Compliance & Quality

• Adhere to Good Clinical Practice (GCP), FDA regulations, HIPAA, and all applicable research regulations.

• Follow Innovo Research policies, SOPs, and protocol requirements.

• Ensure patient safety, confidentiality, and data integrity at all times.

• Support monitoring visits, study initiation activities, audits, and study close-out activities.

• Attend required meetings as invited by Manager/Directors/Site Staff.

• Complete and maintain required trainings both company and study specific

Administrative Responsibilities

• Utilize EMR, CTMS, CRIO, and other electronic systems to document research activities.

• Maintain calendars and schedule patient appointments.

• Complete assigned reports and documentation accurately and timely.

• Perform other duties as assigned to support site operations.