Summary:

Assist the Clinical Operations Team in a multifunctional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.

Responsibilities:

• Assist in the conduct of clinical trials in accordance with the

study protocol, GCP, ICH Guidelines, and companies 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 pre screening 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

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