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St Johns Research Institute (SJRI)
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Study Coordinator - TKA Project

Study Coordinator - TKA Project

St Johns Research Institute (SJRI)

1 - 6 years

3 - 8 Lacs

bengaluru

Posted:None| Platform:

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Skills Required

gcp packaging data collection investigation student coordinator principal investigator management monitoring recruitment auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Non Division User Contact Person Ms. Lincy Thomas Job Details

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

Educate and inform subjects on procedures, duration, potential adverse events, benefits, compensation (if any) and address all issues subject may have

Contact subjects, subject representatives, sub-investigators to facilitate subject enrollment

Assign screening codes to subjects

Follow subject recruitment procedures in compliance with GCP, Ethics Committee (EC) recommendations including approved advertising procedures (if any)

Follow up communications with subjects

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 protocols and procedures are followed with specificity on subject well-being and protocol timelines

Ensure and maintain subject s confidentiality while collecting, filling and transmitting relevant source data (if designated by PI)

Obtain and collate source data from all relevant sources, i.e., medical charts, subject records, laboratory reports, food dairies, physical activity dairies and questionnaires

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

Manage study payments to study subjects, if any

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

Interested candidates may send their Resume to:

The Principal Investigator

TKA Project

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St Johns Research Institute (SJRI)

Biomedical Research

Bangalore

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Study Coordinator - TKA Project