Clinical Research Assistant/Medical Assistant

Must have Medical Assistant Certification or Diploma, or Phlebotomy Certification

Lab processing and collection experience required.

The Clinical Research Assistant assists the team with collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.

Duties/Responsibilities:

• Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and SOPs
• Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
• With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
• Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
• Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
• Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator
• Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team
• Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator
• Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
• Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
• Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person
• Maintain confidentiality of patient protected health information, sponsor confidential information and company confidential information
• Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team
• Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
• Prepare source document charts, copy and/or file medical records and study related documents as required.
• Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
• Other duties as assigned

Education/Experience:

• High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry

Required Licenses/Certifications:

• Phlebotomy if applicable and required by state law
• Intramuscular dose administration and preparation if applicable and required by state law

Required Skills:

• Demonstrated knowledge of medical terminology
• Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Understanding of verbal, written, and organizational skills
• Demonstrated ability to work as a team player
• Demonstrated ability to read, write, and speak English
• Demonstrated ability to multi-task
• Demonstrated ability to follow written guidelines
• Demonstrated ability to be flexible/adapt as daily schedule may change rapidly

Required Physical Abilities:

• Sit or stand for long periods of time
• Communicate in person and by a telephone
• Limited walking required
• Limited to lifting up to 30 pounds