Summary:

The Clinical Research Assistant supports the Clinical Operations Team by performing various tasks related to the collection, documentation, and maintenance of clinical data. This role involves a combination of phlebotomy/laboratory work, data entry, and administrative responsibilities.

Responsibilities:

• Assist in conducting clinical trials according to study protocols, GCP, ICH Guidelines, and SOPs.
• Perform venipuncture, capillary puncture, and other fluid collections as permitted by the protocol and local regulations.
• With supervision, conduct clinical assessments (vital signs, phlebotomy, ECG, etc.) within the scope of the protocol and local regulations.
• Process, package, and ship laboratory specimens as required by the protocol and IATA regulations, if applicable.
• Manage inventory by tracking, ordering, and maintaining laboratory and study-related supplies throughout the clinical trial.
• Enter source data into sponsor or vendor data portals and resolve basic queries in a timely manner under the guidance of the Clinical Research Coordinator.
• Communicate effectively with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team.
• Follow good documentation practices when collecting and transferring data to sponsor/CRO systems and resolving queries, with oversight from the Clinical Research Coordinator.
• Understand the informed consent process, ensuring that study subjects provide and maintain consent throughout the trial.
• Gain familiarity with the regulatory documentation required to initiate, maintain, and close a clinical research trial.
• Participate in patient recruitment activities, including pre-screening potential subjects for clinical research trials via phone or in person.
• Maintain the confidentiality of patient health information, sponsor confidential information, and confidential information.
• Recognize and escalate potential patient safety issues, such as adverse events or serious adverse events, to the Clinical Research Team.
• Assist with cleaning, organizing, and disinfecting patient care areas, labs, and lab equipment as needed.
• Prepare source document charts, copy, and file medical records and study-related documents as required.
• Perform front office duties as needed, including answering phones, scheduling subjects, making reminder calls, and updating patient tracking systems.
• Perform other duties as assigned.

Qualifications:

Education/Experience:

• High School Diploma or technical degree with at least 1 year of relevant experience in the life sciences industry.

Required Licenses/Certifications:

• Phlebotomy certification if applicable and required by state law.
• Certification for intramuscular dose administration and preparation if applicable and required by state law.

Required Skills:

• Knowledge of medical terminology.
• Proficiency in using technology such as computers, Microsoft Office, fax machines, copiers, and multi-line telephones.
• Strong verbal, written, and organizational skills.
• Ability to work effectively as a team player.
• Proficiency in reading, writing, and speaking English.
• Ability to multi-task efficiently.
• Ability to follow written guidelines.
• Flexibility and adaptability to rapidly changing schedules.