A well-known international pharmaceutical company with sites around the globe is looking to hire a Contract CTA / CRA support role. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
- The Clinical Research Site Assistant is responsible for supporting the assigned Clinical Research Associates and investigator sites. Support will include operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and internal standards.
- The Clinical Research Site Assistant will provide technical and logistical support to the assigned Clinical Research Associate.
- The Clinical Research Site Assistant will augment activities performed by assigned Clinical Research Associates, including some clinical trial monitoring support activities, to facilitate meeting study timelines and deliverables
- Assist with study site activation activities and coordinate operational activities to ensure timely site activation
- Supports and/or coordinates central Investigator Review Board (IRB) submissions when needed
- Work with investigator sites to complete critical information for site activation; inclusive of but not limited to Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status
- 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 to the IRB
- 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 within required timelines
- 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 such as documents for protocol amendments and FDA 1572 revisions
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
- 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
- Problem solve identified issues with appropriate timely escalation to the Clinical Research Associate
- 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.
- Assist with periodic review of study files for accuracy and completeness
- Supports investigator sites, Clinical Research Associate, Regional Clinical Site Lead and study teams in preparation for and providing responses to site audits/inspections
Skills and Requirements:
- School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor's degree in life sciences preferred
- 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
- Must be fluent in English.
- Bilingualism is a key asset
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.