NEW JOB OPENING
CLINICAL TRIAL RESEARCH COORDINATOR
IN Oakland, CA, USA!

***Fully Onsite, M-F***

***Contract to hire***

***Some local Travel ***









This position is also responsible for assisting in protecting the health, safety, and welfare of research participants.





Minimum Education

• Bachelor's Degree



Additional Requirements:

• Willingness to obtain IATA/DOT certification prior to start date.

• Current BLS certification required prior to start date.

• Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program.

• Must be proficient in electronic health systems and databases used in research environment and word-processing or willingness to learn within 3 months of hire.

• Demonstrate organizational and communication skills.

• Demonstrate written, verbal, and interpersonal communication skills.

• Demonstrate proficiency in medical terminology.

• Demonstrate attention to detail and accuracy.

• Ability to manage multiple tasks.

• Demonstrate good prioritization and organizational skills.

• Ability to be flexible and dependable.

• Ability to work effectively on cross-functional teams.

• Present professional manner and appearance.

• Demonstrated skill in administrative tasks (i.e., filing, photocopying, faxing, etc.).

• Knowledge of GCP, federal, state, and local regulations including HIPAA and Client policies and procedures.

• Must be able to work in a Labor Partnership environment.



MAJOR RESPONSIBILITIES/ESSENTIAL FUNCTIONS

The primary job duties this position is responsible for achieving are listed in order of importance.

• Assist with obtaining medical records and test results for all projects/participants. ith supervision and certification, perform packaging and shipping of protocol specimens to the Sponsor lab in accordance with IATA/DOT regulations and Sponsor shipping guidelines. Direct issues requiring medical decision-making to the appropriate licensed staff member promptly.

• Provide PI and/or Clinical Trial Nurse with the ongoing informed consent process by coordinating the current consent documents. According to protocol and/or IRB-approved telephone script, collect and document research data in a timely manner, and report the information to the appropriate licensed staff member and PI for assessment. Assist in the collection of protocol-required data with timely and accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions).

• Under specific direction, assist with data entry of study activity onto a case report form (paper or electronic), and maintain a database program to track all study activity (i.e., study enrollment and consents). Assist in maintaining research charts and site regulatory files. Assist in ensuring that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates. Assist in obtaining protocol specific regulatory documents including MDs/RNs licenses and CVs.

• Report any potential protocol violations/deviations to the PI in a timely manner. Support the regulatory team in the maintenance and storage of critical documents required to be maintained and provided to the Sponsor during the





Job Description

Conduct of the trial. With supervision, assist in study closure activities including preparation and collection of closeout documentation, and preparation of study files for distribution to long-term storage.

• Leadership and CommunicationWith direction, communicate compliance and operational needs with internal and external parties, PI, Client Clinical Trials Operations Leader or designee, and Client Office(s) of Clinical Trial Compliance on an ongoing basis. If applicable and with supervision, coordinate IRB communications (e.g., new protocols, amendments, continuing review applications, protocol violations, and adverse events) in accordance with departmental and Client policies and procedures.

• Education and TrainingWith direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Work with an assigned mentor on a regular basis for training and resource questions. Attend Client site-initiated meetings for protocol training including Sponsor-initiated meetings, as requested. Participate as a member of the Clinical Trial Operations Team (CTOT) and attend meetings as requested.

• Quality Improvement With direction, perform routine quality control activities and assist with quality improvement initiatives.

• Systems and Infrastructure Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with Client policies. Adhere to departmental policies and procedures to support quality implementation and conduct of clinical trials and assure maintenance of research documentation in compliance with the protocols and Client policies and procedures. Maintain systems and resources to effectively communicate with and obtain required IRB documentation.

• Staff SupervisionNo supervisory responsibilities.

• GeneralPerform job functions according to the factors listed below under Job Criteria. Other duties as assigned by appropriate management.

• Client conducts compensation reviews of positions on a routine basis. At any time, Client reserves the right to reevaluate and change job descriptions, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees.

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**