Clinical Research Assistant

Job Description

Job Description

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. 

Qualifications

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. 

Experience  

• 2-5+ 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 e-mails.

• 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. There is 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. It 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.

 

Due to the nature of this position, employees are expected to work in person. This is an non-exempt position under the federal and state wage and hour laws, which means you are 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.

 

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities.

 

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.