- Responsible for direct oversight and management of at least 1 (one) active research studies from beginning to end
- Coordinate the operations of research studies in multiple specialties in collaboration with other research coordinators
- Provide oversight of the Research Assistant (RA) staff on the studies
- Provide input regarding IRB correspondence and regulatory documentation. Submit documentation as required.
- Serves as main point of contact with sponsors
- Serve as a liaison between clinical teams, patients, and sponsors
- Create and maintain regulatory binders for each study assigned to
- Manage study data and study results
- Perform direct patient care such as EKGs and vital signs
- Review study candidates’ medical records for study eligibility
- Maintain case report forms, charts and documentation
- Establish and maintain research patient records and databases
- Consent patients for clinical research studies
- Manage investigational devices and drug inventory
- Complete case report forms based upon source documentation and protocol parameters
- Process and ship research specimens per protocol
- Ensure strict compliance with established research protocols and standards along with all applicable laws, regulations, policies, and procedural requirements
- Other duties, as assigned
WORK ENVIRONMENT
- Clinical office environment
- May involve some exposure to hazards or physical risks, which require following basic safety precautions
- Occasional night and weekend work schedules may be required
PHYSICAL DEMANDS
- Frequent use of keyboard and mouse
- Frequent use of computer monitors and other electronic screens
- Frequent standing, walking, bending, and stooping
- Occasional ability to lift 10 pounds
- Ability to differentiate colors according to study protocols
EDUCATION & EXPERIENCE:
REQUIRED
- Associates degree or equivalent degree
- Minimum 1 year experience in clinical research as a Clinical Research Assistant
- Clinical skills
- Excellent communication and organizational skills
- Detail-oriented
- Strong organizational and time management skills
- Familiarity with the Code of Federal Regulations as they pertain to human subject protection
- Strong computer skills
PREFERRED
- Bachelors degree
- MA-P and/or MA-R
- Phlebotomy experience
- Current Healthcare Provider BLS certification
- Preferred experience with site start-up in clinical trials.
- Knowledge of clinical research operations, including Good Clinical Practice guidelines.
TRAVEL
At least 5% travel within the geographic region of the assigned work location.
EEO STATEMENT
ERA Health Research (ERA) provides equal employment opportunities to all without regard to race, color, religion, sex (including sexual orientation or gender identity), national origin, age, disability, genetic information, or other protected status. Applicants and employees with disabilities may be entitled to reasonable accommodations under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is an adjustment to our standard application and/or interview and/or employment process which will ensure an equal employment opportunity without imposing undue hardship on ERA. Please inform our team if you are requesting accommodation to complete any forms or otherwise participate in the application process or perform the essential functions of this role.