Senior Clinical Research Coordinator

We are Hiring!

Senior Clinical Research Coordinator (Site Level)

📍 Guntur | ⏳ Experience: 2–3 Years

CLOUT Research Solutions is looking for a Senior Clinical Research Coordinator (Sr. CRC) to join our team at the site level. The ideal candidate will bring 2–3 years of experience in clinical trial site operations, ensuring compliance, patient safety, and high-quality data delivery.

Qualifications

* 2–3 years of experience as a Clinical Research Coordinator at a trial site

* Doctor of Pharmacy (Pharm D)

* Strong knowledge of clinical trial operations & patient management

Key Responsibilities & Skills

Clinical & Research Knowledge

* Strong understanding of ICH-GCP and global regulatory requirements

* In-depth knowledge of clinical trial protocols, phases (I–IV), and study designs

* Oversee source documentation, CRF/eCRF completion, and query resolution

Regulatory & Compliance

* Prepare & submit documents to Ethics Committees/IRBs

* Maintain Essential Documents (ICF, IB, Delegation Log, SAE reports)

* Ensure site compliance with SOPs, GCP, and sponsor/CRO requirements

* Confidently manage audits and monitoring visits

Patient & Site Management

* Handle subject screening, recruitment, consent, and follow-up

* Monitor and report SAEs/AEs accurately

* Build patient trust and ensure adherence to study visits

* Manage multiple protocols simultaneously

Documentation & Data Management

* Proficiency in eCRF, CTMS, and EDC platforms

* Maintain SMF/TMF compliance with attention to detail

* Perform data entry, QC, reconciliation & timely data lock

Leadership & Team Skills

* Supervise and mentor junior CRCs and site staff

* Delegate tasks effectively using a Delegation of Authority log

* Coordinate with investigators, nurses, lab staff, and CRO monitors

Communication & Interpersonal

* Strong written & verbal communication with CROs, sponsors, and investigators

* Confident in SIVs, IMVs, and close-out visits

* Skilled in conflict management & negotiation

Technical & Analytical

* Knowledge of lab procedures, medical terminology, drug accountability & storage

* Proficiency in MS Office (Excel, Word, PowerPoint)

* Analytical mindset to identify protocol deviations & compliance issues

Organizational & Time Management

* Prioritize multiple studies at different stages

* Strong scheduling & follow-up for patient visits and site activities

* Deliver within tight timelines

Why Join Us?

At CLOUT Research Solutions, you will be part of a growing organization dedicated to advancing clinical trials across India. We provide a collaborative environment where your expertise will shape impactful healthcare research.

📩 Interested candidates can apply by sending their CV to

contact@cloutclinical.com