Vacancies
POSITION : Clinical Research Coordinator (CRC)
LOCATION : Mumbai & Thane
OPEN POSITIONS : 2
POSTED ON : 8th June 2020
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Pharm/ BSc / Biotech / BAMS / BHMS + Clinical Research Degree / Diploma
- With 0 – 6 months experience in Clinical Operations
- Candidate must possess good communication skills
- Understanding of Human healthcare related topics
- ICH-GCP knowledge is must
- Ready to travel within Mumbai at various trial sites
Job Description: Clinical Research Coordinator (CRC)
- This would be an onsite job profile
- Will have to help the investigator with documentation work
- Take care of documentation of Informed Consent procedure
- Take care of proper documentation at site (Source data, CRFs, all logs & forms, etc)
- Ensure that all CRFs are completed and correctly transcribed from source documents
- Coordinate with Central / local labs for visit specific lab procedures
- Ensure that all visit specific study procedures are done as per the protocol
- Find out protocol deviations at site and document them properly
- Ensure proper IP accountability at site
- Coordinate with subjects for reminder of follow up visits
- Assist the investigator during subject follow up visits
- CRC will be the coordination link between sponsor and investigator
- Ensure proper study conduct as per ICH GCP will be the responsibility of site
POSITION : CRA / SR CRA (Clinical Research Associate)
LOCATION : Mumbai & Thane
OPEN POSITIONS : 1
POSTED ON : 12th June 2020
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Medical, Pharma, Lifesciences Graduate + Clinical Research Degree / Diploma
- Minimum 2 – 3 year of relevant experience in site monitoring & Clinical Operations
- Good communication & interpersonal skills
- ICH-GCP knowledge is a must
- Ready to travel within Mumbai at various trial sites
- Good organizational and administrative skills (knowledge of word, excel)
Job Description: CRA / Sr. CRA
- Work as primary project in charge accountable for study progress as per defined timelines
- Involved in all clinical operations activities such as site feasibility, site selection, monitoring and closeout
- Responsible for recruitment at sites. Need to develop new recruitment strategies as per study need and implement the same to enhance recruitment speed
- He/ She will be the Point of Contact (POC) for all 3rd party vendors (including but not limited to) investigators. central laboratory, radiology centers (if applicable), statistician, Ethics committee etc
- Responsible for IP management at site, Training and mentoring of in-house study team
- Communicate with account department with respect to project financial aspects and vendor payments
- Literature search to support study documents (protocol/ IB/ CSR)
POSITION : Project Lead / Manager- Clinical Development
LOCATION : Mumbai & Thane
OPEN POSITIONS : 1
POSTED ON : 12th June 2020
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Medical, Pharma, Lifesciences Graduate + Clinical Research Degree / Diploma
- Minimum 7 – 10 years of experience in site monitoring and Clinical Operations
- Good communication, interpersonal & project management skills
- ICH-GCP knowledge is a must
- Ready to travel within Mumbai at various trial sites
- Good organizational and administrative skills (knowledge of word, excel)
- Willingness to act accountably in project / trial management
- Presentation, negotiation and conflict resolution skills
Job Description: Project Lead / Manager- Clinical Development
- Work as a primary project in charge accountable for study progress as per defined timelines
- Involved in all clinical operations activities such as site feasibility, site selection, monitoring, and closeout with CRA`s
- Responsible for recruitment at sites. Need to develop new recruitment strategies as per study need and implement the same to enhance recruitment speed
- He/ She will be the Point of Contact (POC) for all 3rd party vendors (including but not limited to) investigators. central laboratory, radiology centers (if applicable), statistician, Ethics committee, etc
- Responsible for IP management at site, Training and mentoring of the in-house study team
- Communicate with the accounting department with respect to project financial aspects and vendor payments
- Literature search to support study documents (protocol/ IB/ CSR)
- Estimations and finalization of expenses towards clinical trial
- Periodic review of trial progress in view of timely completion of project in proposed budget
- Recruitment, selection & training of the team
