Responsibilities / Job Duties :
Clinical Research Assistant (Medical Assistant)
Summary :
The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional 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
Duties / Responsibilities :
- Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and company's 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 prescreening 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
Minimum Education and Experience Qualification Requirements :
Qualifications
Education / Experience :
High School Graduate and / or technical degree with minimum of 1 year of relevant experience in life sciences industry
Required Licenses / Certifications :
- Medical assistant diploma / certification
- Phlebotomy if applicable and required by state law
- Intramuscular dose administration and preparation if applicable and required by state law
Required Skills :
- Demonstrated knowledge of medical terminology
- Demonstrated ability to use the following technology : Computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Understanding of verbal, written, and organizational skills
- Demonstrated ability to work as a team player
- Demonstrated ability to read, write, and speak English
- Demonstrated ability to multi-task
- Demonstrated ability to follow written guidelines
- Demonstrated ability to be flexible / adapt as daily schedule may change rapidly
Required Physical Abilities :
- Sit or stand for long periods of time
- Communicate in person and by a telephone
- Limited walking required
- Limited to lifting up to 30 pounds
Schedule / Shift : 40 hours a week, M-F 7 AM - 4 PM
Benefits :
- Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances)
- Health Benefits / Dental / Vision (Medix Offers 6 different health plans : 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan.
Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met.
If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).)
- 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1 / 1, 4 / 1, 7 / 1, and 10 / 1)
- Short Term Disability Insurance
- Term Life Insurance Plan
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).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment.
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.