Clinical Research Coordinator (CRCs) have a very dynamic and challenging job that offers a host of opportunities for growth and career development. This program provides skill based training, as well as exceptional Coordinator development opportunities and hands-on experiences needed to create a well-rounded, fully competent CRC.”
“CRCs are responsible for the organization, coordination and overall integrity of a research project. CRCs receive direction from principal and co-investigators. Responsibilities include: protocol development, screening, recruiting and enrolling participants, consenting, collecting data, scheduling, dispensing study drugs and managing the use of devices, ensuring accuracy of documentation, and maintaining databases.”
ISCRI is dedicated to provide the quality services to various clinical research companies.
ISCRI services facilitate the sponsor/CRO in the conduct of feasibility services to the companies in various therapeutic areas with quality & less turnaround time.
ISCRI services facilitate the Sponsors/CRO in collecting the EC submission documents, print them and submit to the EC for approval and follow up till the receipt of approval of the documents from EC.
ISCRI prepares investigators site binders, study log binders, print mini protocols, study logs, various handouts, laminations of inclusion and exclusion criteria, IVRS guide, eCRF guide, stickers, envelops & necessary stationeries required for the conduct of study and send them to site prior to site initiation.
ISCRIservices help sponsors/CROs in execution of CDA to site initiation for a particular site. We do follow up for CDA execution, conduct of feasibility , follow up for regulatory documents(Essential documents), appointment for site qualification visit for CRAs, follow up with translator for translation of ICFs in local languages, EC Submission, CTA execution with investigators, sending Site initiation package, appointment with study team for site initiation for CRAs.
ISCRI facilitates the investigator/sponsor/CRO in placement of experienced, trained, qualified study coordinators for the sites from site initiation to site close out visit. Also we provide site coordinators from CDA executions to site closeout visits.
- Single point of contact between investigator, Patient & CRA.
- Feasibility.
- Identifying & Selecting study team.
- EC Submission & follow up with EC for Approvals.
- Prescreening subjects for the study.
- Reviewing database for identifying subjects for the study.
- Assist in informed consent process documentation.
- Screening and randomization of subjects in IVRS / IWRS.
- Ensure source data is complete as per protocol.
- Transcribe CRF or eCRF with error free.
- Ensure to have less number of queries & Query resolutions in CRF / eCRF.
- Patient retention.
- Sending samples to central / local labs.
- Maintaining Investigator site file.
- Tracking enrollment.
- Ensure 100% follow up with patients.
- Maintaining drug accountability.
- Maintaining documents accordingly.
- Assist CRA during monitoring visit & audit preparation.
- Assist CRA during site close out visit.
- As instructed by Investigators / CRA / Sponsors / ISCRI.
Site Coordinator Placement:
- ISCRI recruits experienced site coordinators to assist investigators and study team throughout the study duration. ISCRI also has a unique training methodology in order to create an internationally accepted level of knowledge, education and experience, especially in onsite level documentation and site management.
Interim Analysis:
- ISCRI team will perform interim analysis of site performance giving equal importance to recruitment, quality and timelines.
- ISCRI provides back-up coordinators who are readily available to sites, in case if past audit findings and quality issues at sites were identified primarily due to inexperienced staff (especially site coordinators) and staff turnover.
Quality output:
- Assures quality output at the site level and ensures that there are no major findings during audits. Our goal is to create a lasting impact on your success.
Reporting System:
- We maintain transparency in reporting system to achieve our success. Risks are identified at an early stage to avoid late stage problems.
Training Study Team:
- ISCRI owns responsibility in training the investigator and study team on ICH-GCP, Schedule Y and other regulatory guidelines.
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