Opportunity to work as Clinical Research Associate @ Manipal Acunova Ltd.
Job Description
The responsibility of a Clinical Research Associate (CRA) is to perform all clinical monitoring aspects of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.
Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM
Preparation, conduct and reporting of site selection visits
Negotiation & obtaining Investigator agreement on site budget, payment to the sites
Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner
Maintenance of TMF and Site specific file
Scanning & uploading documents into shared drive
Transmission of documentation into project files
Preparation of regulatory dossier, regulatory submission and follow-up.
Preparation of EC dossier, EC submissions and follow-up
Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting
Development of meeting materials along with required presentations for investigators meeting.
Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
Co-ordinating the IP request between sites and pharmacist/vendor/sponsor
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:R&D
Role:Clinical Research Associate/Scientist
Keyskills
Clinical Research clinical trial clinical research associate cra clinincal monitor
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
Worked in OPHTHALMOLOGY or ONCOLOGY or DIABETES studies Clinical Studies I-IV
Ability to interact professionally with clients/vendors
Excellent interpersonal, verbal and written communication skills and ability to work in a team
Effective time management skills and prioritize tasks to manage study timelines
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word etc, sound presentation skills
Willing to travel a minimum of 65% on average
Company Profile:
Manipal Acunova Ltd.
Ecron Acunova provides end-to-end services for Phase I - IV clinical research, including Clinical Trial Management, Clinical Data Management, PK/PD services and Central Lab. Ecron Acunova has research facilities in Asia as well as an established presence in various parts of Europe and the United States. As regional experts, we operate each region as a priority market. Our European HQ is in Frankfurt, Germany, in the United States our HQ is in Princeton, NJ and our Asian HQ is in Bangalore, India. We offer clinical development services to the pharmaceutical, biotechnology, nutritional, device and medical diagnostics industries. Our service quality, therapeutic expertise and global reach have allowed us to grow rapidly, building a list of demanding clients. We provide an attractive package of services coupled with the ability to rapidly conduct clinical trials utilizing a world class delivery platform.
Click here to apply
Job Description
The responsibility of a Clinical Research Associate (CRA) is to perform all clinical monitoring aspects of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.
Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM
Preparation, conduct and reporting of site selection visits
Negotiation & obtaining Investigator agreement on site budget, payment to the sites
Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner
Maintenance of TMF and Site specific file
Scanning & uploading documents into shared drive
Transmission of documentation into project files
Preparation of regulatory dossier, regulatory submission and follow-up.
Preparation of EC dossier, EC submissions and follow-up
Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting
Development of meeting materials along with required presentations for investigators meeting.
Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
Co-ordinating the IP request between sites and pharmacist/vendor/sponsor
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:R&D
Role:Clinical Research Associate/Scientist
Keyskills
Clinical Research clinical trial clinical research associate cra clinincal monitor
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
Worked in OPHTHALMOLOGY or ONCOLOGY or DIABETES studies Clinical Studies I-IV
Ability to interact professionally with clients/vendors
Excellent interpersonal, verbal and written communication skills and ability to work in a team
Effective time management skills and prioritize tasks to manage study timelines
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word etc, sound presentation skills
Willing to travel a minimum of 65% on average
Company Profile:
Manipal Acunova Ltd.
Ecron Acunova provides end-to-end services for Phase I - IV clinical research, including Clinical Trial Management, Clinical Data Management, PK/PD services and Central Lab. Ecron Acunova has research facilities in Asia as well as an established presence in various parts of Europe and the United States. As regional experts, we operate each region as a priority market. Our European HQ is in Frankfurt, Germany, in the United States our HQ is in Princeton, NJ and our Asian HQ is in Bangalore, India. We offer clinical development services to the pharmaceutical, biotechnology, nutritional, device and medical diagnostics industries. Our service quality, therapeutic expertise and global reach have allowed us to grow rapidly, building a list of demanding clients. We provide an attractive package of services coupled with the ability to rapidly conduct clinical trials utilizing a world class delivery platform.
Click here to apply
0 comments:
Post a Comment