Study Start Up Assistant

RHL


Job ID :

7989


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Surrey,Surrey,


Key Skills :

study start up, CTA, CRA, clinical research, contract, pharmaceutical, tmf, investigator, site activ


Salary :

Negotiable


Date Posted :

26 Jul, 2017



Company Name :

RHL


Location1 :

Surrey




Job Category :

Clinical Monitoring Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

upto 15%





Description

Fantastic opportunity for a Study Start Up Associate to join a global pharma company on 12 month contract. Home Based.

ROLE RESPONSIBILITIES
Responsible for Clinical Research Associate and investigator site support for assigned sites.

Clinical Trial Site Activation & Conduct
* Assist with study site activation
* Register investigator sites as required
* Supports and/or coordinates central Investigator Review Board (IRB) submissions
* Support local IRB workflow from submission through approval and support reporting of safety information
* May facilitate coordination of Clinical Research Associate and study team responses
* Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner
* Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval
* Communicate site approvals to the Clinical Research Associate, Regional Clinical Site Lead and relevant study team members
* Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed
* Work with investigator sites to complete required ongoing study documents
* Tracking and management of Case Report Forms (CRFs), queries and clinical data
* Submit within required timeframes all needed documentation, updates and tracking including but not limited to Trial Master File documentation, site activation status, protocol amendment status
* Support Clinical Research Associate with patient recruitment, study progress and metrics updates as needed; accurately update and maintain clinical systems that track site compliance and performance within project timelines
* Assist with site payments and tracking as needed
* Maintain administrative and Study files
* Facilitates the collection and maintenance of regulatory and site documentation for the Trial Master File and site file
* Assist the Clinical Research Associate with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

QUALIFICATIONS
* Minimum 2 years relevant experience in clinical site management
* Experience in study activation and site management is an asset
* Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
* Bilingualism is a key asset

Job Title: Study Start Up Associate
Reference No: 235024
Location: Home Based
Job Type: 12 months contract


Company Name:

RHL


Headquarters:

The Cedars,Church Road


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

TN231RQ


Website:

www.rhl.co.uk


Employees:

less than 100


Industry:

Pharmaceutical Recruitment


City:

Ashford


Phone No. :

01233 658018


For more information,visit www.rhl.co.uk.

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