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