Clinical Research Coordinator

2 days ago

Gurgaon, India SYS Research Full time

**Roles and Responsibilities of Clinical Research Coordinator (CRC)**
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
- Reviews and comprehends each assigned protocol including study proceedings and timelines.
- Coordinates approval of new study agreements and contracts.
- Coordinates and attends sponsor Site Selection visits, Routine monitoring visits, and study close out visits.
- Completes case report forms. Extracts data from patient file (Source documents) in a timely manner.
- Responds to data clarification requests in a timely manner.
- May attend Investigator meetings requiring travel and report pertinent information back to research team members.
- Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, like study protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training.
- Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits.
- Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations.
- Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.
- Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure protocols are followed and that there is timely documentation and submission of study data.
- Performs specimen processing and shipment of biological specimen duties.
- Assists with development of study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable IRB/IEC and applicable regulatory requirement.
- Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.
- Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research.

**Salary**: ₹14,500.00 - ₹38,500.00 per month

**Benefits**:

- Internet reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Gurgaon, Haryana: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Higher Secondary(12th Pass) (preferred)

**Experience**:

- total work: 1 year (preferred)

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