We are hiring for a Research Assistant/Medical Assistant in the Lafayette area for a growing organization, conducting clinical research trials.

This position is a 90-day provisional contract. Opportunity to be brought on on for contract extension will depend on performance AND busniess needs. Paid holidays and sick time accrual available during contract period. 

The ideal candidate will be a medical assistant that has phlebotomy experience 

Summary:
The Clinical Research Assistant supports the Clinical Operations Team in multiple capacities to ensure the smooth execution of clinical trials. This role involves assisting with data collection and documentation, performing laboratory and phlebotomy procedures, maintaining study supplies, and providing administrative support to ensure compliance with study protocols and regulatory standards.

Responsibilities:

• Assist in the conduct of clinical trials in accordance with study protocols, Good Clinical Practice (GCP), ICH Guidelines, and internal Standard Operating Procedures (SOPs).

• Perform venipuncture, capillary puncture, and other specimen collections within the scope of the protocol and in compliance with local laws and regulations.

• Under supervision, perform clinical assessments such as vital signs, phlebotomy, and ECGs in accordance with study requirements.

• Process, package, and ship laboratory specimens per protocol and IATA regulations, as applicable.

• Track, order, and maintain inventory of laboratory and study-related supplies throughout the course of the clinical trial.

• Enter source data into sponsor and/or vendor data systems and assist in resolving basic queries under the direction of the Clinical Research Coordinator.

• Communicate professionally with coworkers, study subjects, sponsors, CROs, and vendors as directed by the Clinical Research Team.

• Apply good documentation practices (GDP) when collecting and transferring data to sponsor or CRO systems.

• Understand the informed consent process and ensure the protection of study subjects through proper documentation and adherence to protocol.

• Support basic regulatory documentation and administrative tasks necessary to initiate, maintain, and close clinical trials.

• Participate in patient recruitment activities, including prescreening potential participants via phone or in person.

• Maintain confidentiality of all patient protected health information and sponsor-related materials in compliance with HIPAA and company policies.

• Promptly escalate potential patient safety issues such as adverse events (AEs) or serious adverse events (SAEs) to the Clinical Research Team.

• Clean, organize, and disinfect laboratory and patient care areas as needed.

• Prepare source document charts and manage study files, including copying, scanning, and filing medical and study-related documents.

• Perform front office duties as needed, such as answering phones, scheduling subjects, making reminder calls, and updating tracking systems.

• Perform other duties as assigned.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

^*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.