Clinical Research Assistant / Licensed Practical Nurse (LPN)

Essential Functions:

• Must do patient assessment on every study patient
• Ability to draw, process and send to central study lab per protocol.
• Performs venipuncture, arterial and capillary punctures on patients including teens, adults, handicapped and elderly. 
• Identifies and labels specimens per protocol. Must be ablet to do PK samples, urine pregnancy test, COVID, Flu tests
• Must be able to do Protocol procedures such as EKG’s, Holter monitor, spirometry, breathing test
• Knowledge of electronic medical records data entry and the ability to complete study protocol paperwork and request forms.
• Cleans and sterilizes equipment and work area following safety, cleanliness and infection control procedures.
• Inventories lab supplies, other supplies and places orders.
• Maintain drug accountability record sheets and put accountability into EMR systems. Be willing to learn study specific EMR systems including but not limited to IntElligo, Medidata, and Inform.
• Maintains patient confidentiality.
• Oversees and completes all trial paperwork and makes sure they are completed on time.
• Completes individual trial education. Keeps Clinical Trial Training up to date-GCP, Ethics and Human Protection training, ICH, Informed Consent, Quality Assurance, Participant Safety, Adverse Events, and specific trial education.
• Make sure all government, state, and IRB regulations and standards are followed. 
• Make sure all ICH/GCP guidelines are followed.
• Will assist study manager/coordinator in entering data into study EMR system and Elligo EMR system and central lab.
• Should be able to obtain flu, strep and Covid swabs per protocol and be knowledgeable of protective safety attire.
• In person regular and punctual attendance.

Skills/Abilities

• All candidates must demonstrate current competencies applicable to the position.
• Knowledge of phlebotomy techniques.
• Knowledge of clinic protocols and policies.
• Must have good computer skills
• Other job functions as directed.
• Must demonstrate current competencies (efficient and effective blood draws) applicable for the position.
• Knowledge of clinic/medical practice procedures.
• Must be able to recruit research participants.
• Able to maintain quality standards, ensuring the integrity of the data.
• Must have excellent written, verbal communication, and people skills.
• Must be skilled in customer service and have a pleasant and courteous demeanor.
• Must be able to respond to stressful or emergency situations in a calm and effective manner.
• Must have the ability to work cooperatively as a member of office staff and team.

Mental/Physical Requirements:

• Standing six to eight hours per day, walking, bending, and reaching.
• Must be able to lift up to 30 pounds of supplies and equipment.
• Occasional stress when dealing with priorities and anxious patients.

Qualifications: Education:

State Certification as LPN

Must complete GCP, human subjects, Elligo and IRB and specific training for each protocol.

Licenses and Certifications:

Certification LPN and CPR