Clinical Research Assistant

Location: Eastfield Estates

JOB SUMMARYA 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.

Education 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.

Experience2-5+ years of experience

Knowledge of OSHA and FDA regulations regarding clinical research is a plus.

Skills & Competencies Maintaining 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.

Prepare/maintain records, write reports, respond to correspondence, and respond to…