JOB DESCRIPTION
Clinical Research Coordinator (CRC)
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.
JOB RESPONSIBILITIES
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
- Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
- Works with the PI to develop and implement recruitment strategies in accordance with EC requirements and approvals.
- Conducts or participates in the informed consent process including interactions with the EC and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Registers participants to the appropriate coordinating center (if multi-site study).
- Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
- Coordinates participant tests and procedures.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Maintains study timelines.
- Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Washington University Policy on Investigational Drug/Device Accountability.
- Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
- Retains all study records in accordance with sponsor requirements and university policies and procedures.
- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
- Assists PI in preparation of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.
- Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management
QUALIFICATION REQUIREMENTS
- Bachelor’s degree in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 25% on a regular basis
A DOSSIER COMPRISES
1. Curriculum Vitae
2. Identity card/passport photo
3. Qualifications
4. Job application
CONTACT INFORMATION:
Contact person: Ms.Huyen 0988-558-317
Address: Horison tower - 40 Cat Linh, Dong Da, Ha Noi
Website: http://vietstar-research.com/