Clinical Research Assistant

About the Role

A Clinical Research Assistant is an entry-level research position responsible for performing a variety of duties, including coordinating aspects of clinical trial protocols such as study initiation, recruitment, study visits, monitor visits, regulatory compliance, study close-out, and other administrative tasks.

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 opportunities.
  • Schedule research appointments and coordinate participant visits.
  • Document activities 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 a timely manner within the Innovo-specific CTMS system.
  • 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.

Requirements

• High School Diploma or equivalent; Bachelor's Degree preferred.
• Phlebotomy experience/certification preferred.
• Certified Nurse Assistant Certificate and/or graduation from an accredited program for medical assistants is a plus.
• 2-5+ years of experience.
• Knowledge of OSHA and FDA regulations regarding clinical research is a plus.

Skills & Competencies

• Ability to maintain confidentiality is a must.
• Knowledge of medical terminology is a plus.
• Knowledge of electronic medical records and scheduling systems is a plus.
• Experience working with providers and other department staff is a plus.
• Phlebotomy experience or willingness to learn.
• Ability to apply and modify professional research principles, methods, and techniques to provide ongoing patient care.
• Skilled in identifying problems and recommending solutions, and understanding common safety hazards and precautions for maintaining a safe working environment.
• Ability to prepare/maintain records, write reports, respond to correspondence, and respond to emails.
• High level of computer competency.
• Ability to maintain quality control standards.
• Ability to react calmly and effectively in all situations.
• Ability to work independently, prioritize, and work in a team environment.

Working Conditions

This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and scanners.

• Frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment.
• Varied activities include standing, walking, reaching, bending, and lifting.
• Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination.
• Requires standing and walking for extensive periods of time.
• Occasionally lifts and carries items weighing up to 50 pounds.
• Requires corrected vision and hearing to normal range.
• Employees are expected to work in person.
• This is an exempt position under federal and state wage and hour laws, meaning you are not eligible for overtime pay beyond your salary.
• Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand.