INDORIV CLINICAL

 URL: www.indorivclinical.com

For Microbiology / Biotechnology students

Job Title: Clinical Research Coordinator Level  II and III 

Job Location: Kolkata across various Hospitals

Job Description 

Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.

Essential Functions

• Provide 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 the FDA and other regulatory bodies governing the conduct of clinical research;

• Recruit and screen patients for clinical trials and maintain subject screening logs;

• Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits;

• Design and maintain source documentation based on protocol requirements;

• Schedule and execute study visits and perform study procedures; 

• Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness;

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

• Monitor subject safety and report adverse reactions to appropriate medical personnel; 

• Correspond with research subjects and troubleshoot study-related questions or issues; 

• Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards; 

• 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.

• Provide training to new investigator site staff members on study-specific topics and requirements. 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.

Qualifications

• Bachelor's Degree 

• Fresher / 1 years’ relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training and experience 

• Working knowledge of clinical trials. In case of Fresher 3 Month Training period 

• Working knowledge of the principles of Good Clinical Practices (GCP)

• In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules

• Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing

• Good skill in using MS Windows and Office applications such as Access, Outlook and Word

• Excellent interpersonal skills

• Ability to pay close attention to detail

• Ability to establish and maintain effective working relationships with coworkers, managers and clients

• Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies

PAY RANGE: Rs. 25,000/- pm LEVEL II and III CRC 

 Interested students are requested to mail their RESUME at: anant@indorivclinical.com within 7 days by mentioning "From St. Xavier's College"