Clinical Research Coordinator-Onsite - Sigma Inc
Newark, DE 19713
About the Job
FM17016 Clinical Research Coordinator,Newark, DE, 6 Months
Sigma Inc is currently looking for a Clinical Research Coordinator to work onsite in Newark, DE
Shift timings:
6 month contract with potential to convert based on performance. Onsite position. M-F but some Saturday may be needed. Typically 8am- 5pm but may need to flex earlier to meet patients.
Responsibilities:
General Administrative:
Requirements
Sigma Inc is currently looking for a Clinical Research Coordinator to work onsite in Newark, DE
Shift timings:
6 month contract with potential to convert based on performance. Onsite position. M-F but some Saturday may be needed. Typically 8am- 5pm but may need to flex earlier to meet patients.
Responsibilities:
General Administrative:
- Continues to display a mastery of Senior Clinical Research Associate duties and responsibilities
- Adheres to Standard Operating Procedures (SOP), GCP, all regulatory practices as established by law, and company policies and procedures
- Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with Food and Drug Administration (FDA), GCP, and ICH Guidelines
- In collaboration with the PI, incorporates knowledge of protocol to identify potential study participants according to inclusion/exclusion criteria
- Develops processes for monitoring the status of study subjects as they progress through the study protocol assessment timeline
- Maintains up-to-date knowledge for operation and use of study specific equipment and technology
- Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of them during participation in a clinical trial
- Serves as an advocate for human subjects by establishing rapport with participants through open, transparent communication
- Educates the subject on study protocol and procedures
- Maintains the study site files according to GCP
- Maintains subject participant records according to GCP
- Demonstrates initiative and actively seeks new opportunities for continuous learning by attendance at educational and professional development training opportunities .
- Reviews source document templates for protocol accuracy identifying any errors or improvements needed to be made for data integrity prior to subject screening
- Performs tasks required by a protocol, which may include obtaining medical history, phlebotomy, Electrocardiogram (EKG), and other required tests, assessments, or procedures
- Develops in depth knowledge of study-specific requirements for reporting subject safety issues to the sponsor, institutional review board (IRB), FDA, and other regulatory agencies.
- Monitors, detects, and reports adverse events per the requirements of the sponsor, regulatory bodies, and site policies. Coordinates and gathers information from a variety of sources to ensure subject safety
- Prepares and submits regulatory documents in an accurate and timely manner under the supervision of the PI and appropriate management
- Utilizes or acquires knowledge of disease processes to recognize -subject's change(s) in condition
- Regularly evaluates the study subjects' condition and communicates concerns, with documented follow up to the PI, to ensure subject safety
- Accurately documents study subject activities as it pertains to the clinical study according to the principals of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)
- Maintains environmental integrity for investigational study product, administration, accountability, and storage according to study protocol and sponsor requirements
- Ensures appropriate storage, access, and maintenance of records pertaining to investigational product
- Conducts routine assessments to evaluate the subject's response to and adherence to investigational product orders, and communicates observations/results to the PI, sponsor, and IRB as appropriate
- Consults with PI regarding the appropriate administration of investigational product
- Administers the investigational product according to the parameters of the study protocol, including local law, and under the direction of the physician
- Ensures safe handling of biological specimens
- Meets with the study monitor to review, verify, and correct all data entered onto the case report form and to ensure appropriate maintenance of study records
- Conducts ongoing assessments of the overall study execution within the facility/practice, communicating concerns to the Director, PI, study sponsor or IRB as needed
- Tracks and coordinates potential site study subject stipend disbursement
- Ensures appropriate billing charge documents are submitted for reimbursement
Requirements
- Bachelor's Degree or an equivalent combination of education and experience.
- 2+ years' healthcare experience with Renal experience preferred. Research experience preferred
- Willing to pursue CCRC or SoCRA certification when eligible.
- Current appropriate state licensure if applicable.
- Proficient with PCs and Microsoft Office applications.
- Good communication and organizational skills.
- Ability to work independently.
Source : Sigma Inc