Clinical Study Coordinator / Clinical Research Lazio

Clinical Study Coordinator / Clinical Research
Roma
Lazio, Lazio

Are you looking for your next opportunity in Clinical Research?

Do you want to work for an industry leading company that offers you an excellent benefits package and supports career progression?

If so, come and join us!

**Day to day responsibilities will include**:

- Providing clinical research support to investigators to prepare for and execute assigned research studies, including: Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data

- Attend all relevant study meetings

- Collect and submit regulatory/ethics documentation as required by relevant regulatory bodies governing the conduct of clinical research

- Design and maintain source documentation based on protocol requirements

- Schedule and execute study visits and perform study procedures

- Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics

- Assist with study data quality checking and query resolution

- Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring

- Record, report and interpret study findings appropriately to develop a study-specific database

- Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards

- Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records

- Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies

- Assist research site with coverage planning related to staffing and scheduling for research projects.

- BS/BA in life sciences or educational equivalent and/or relevant work experience in a clinical environment or medical setting

- Knowledge of medical terminology

- Knowledge of clinical trials, combined with in-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules

- Must have previous experience of EDC entry and query resolution

- Ability to pay close attention to detail

- Excellent interpersonal skills with the ability to establish and maintain effective working relationships with co-workers, managers and clients

- Good organizational skills with the ability to pay close attention to detail