Parexel Released Job Openings On 29/11/2022.Parexel International is an American provider of biopharmaceutical services. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process
Vacancy Details:
Parexel Recruiting Bachelor of Science, Arts or Life Sciences with 02+years experience for Site Activation Partner position.Complete Details for the Site Activation Partner as follows.
Important Details :
- Location : Work From Home
- No of Vacancies:Not Disclosed
- Details of Salary: Not Disclosed
- Opening date for online Application: 29/11/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
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Clinical Trial Site Activation Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation Register investigator sites and Client stakeholders in Client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines Manage and coordinate with other supporting roles to ensure timely site activation and operational activities Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements Coordinate the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent) Support investigators sites with local IRB workflow from preparation, submission through approval Assist with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed Collaborate with the Study Team on the development and readiness of sites electronic Investigator Site File (eISF) when utilized and act as primary point of contact for the sites and manage the Site Operations/CRO monitor access to eISF prior to Site Initiation Visit (SIV) Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
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