Clinical Research Coordinator-Onsite

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:

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 .

Conduct of Research:

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

Financial Management:

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.