Study Coordinator- Tka Project

2 days ago

Bengaluru Karnataka, India St. John's Research Institute Full time

**Brief Description about the Project**

Group 1 (Test): Participants in group 1 will receive standard of care with protein supplement for 42 days.

Group 2 (Control): Receive standard of care for 42 days

The study will be conducted over 42 (6 weeks) days and will follow a randomized, open-labeled, controlled study design at a single center. Eligible participants will be randomly assigned at a 1:1 ratio to either the control or test group. Participants will receive either standard of care or standard of care plus protein supplement for 42 days. Protein supplementation will begin one week before the surgery, following the completion of laboratory investigations. The study will comprise of five key assessment points: screening (Visit 1, day -14 to -7), baseline/randomization -day 1 of protein supplementation (Visit 2, day -6 to Day 0), follow up (Visit 3, Day 7 - telephonic), follow up (Visit 4, Day 14, Onsite), final visit (Visit 5, Day 42, onsite). The efficacy and safety of the test supplement will be evaluated in comparison to the control group

**Study Coordinator**

**No. of Vacancy**:One

**Preferred Qualifications**:Preferably Life science graduate

**Experience**:Experience (Min 1 year)

**Language**:English, Hindi, Kannada (Read, Write & Speak)

**Salary**:Rs. 25,000/-p.m

**Location**:Bangalore

**Roles and Responsibilities**:

- Work under the guidance of the Investigator - Assist in the informed consent process
- Follow ‘Schedule of Assessments’ as defined in protocol in coordination with the study team
- Coordinate laboratory procedures including sample collection, processing, packaging and shipping as per approved protocol
- Ensure relevant and designated authorities sign source data
- Compilation of all available data in a systematic manner to allow for immediate review by supervising personnel
- Transcribe collected data from source document to CRF as per instructions
- Ensure all fields in CRF are complete and accurate
- Report non availability of data to Investigator / Manager
- Evaluate source data for inconsistencies (e.g. abnormal laboratory value)
- Report all study inconsistencies / issues as appropriate - Resolve all the data queries in assistance with study team / monitor
- Identify all associated problems with data collection (e.g. non availability of specific report, no signature of relevant authority). Report all problems to Manager
- Report adverse events (AE) and serious adverse events (SAE) as per procedural guidelines to all relevant personnel including P.I., study monitor, study sponsor and EC
- Record important communications
- Maintain, update and complete study files / Site Master File (SMF)
- Reorder study supplies (e.g., lab kits, CRFs) as necessary
- Coordinate with monitor for all the site visits [Site Initiation visit (SIV), Routine Monitoring visit (RMV)]
- Coordinate with sponsor and/or regulatory for audits and inspections
- Coordinate study closeout activities

The Principal Investigator

TKA Project

St. John's Research Institute

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