Start-Up Associate/Sr. Start-Up Associate - Contractor (USA)

At Allucent ™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate/Sr. Start-up Associate (Contractor) to join our A-team. As Allucent , you will coordinate and support local site start-up activities of Allucent Study Start-up & Site Intelligence. This may include essential record collection, Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities, and country and site Informed Consent (ICF) review. The Start Up Associate (Contractor) will support communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.
In this role your key tasks will include:
General activities

- Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)

- Ensure site start-up milestone planned dates are reliable and up to date in CTMS

- File documents in the (e)TMF for which they are the document owner

- Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner

- Complete handover of site to CRA at time of SIV

IEC/IRB submission/approval activities

- Assist sponsor and sites in the preparation, compilation, submission and maintenance of ethical requirements and documentation required by IEC/IRB for clinical trials at local level

- Providing and reviewing relevant documents in compliance with ethical requirements and per local legislation

- Support in interactions with IEC/IRB

- Assist in the preparation and compilation of answers for questions raised by the IEC/IRB and submit the answers

- Complete adaptation of Master ICF to country and/ or site-specific requirements

Essential Document collection activities

- Assist in the preparation of the site-specific Essential Records Package and send package to sites

- Complete collection and first review of Essential Records

- Provide the Global Essential Document Reviewer with the collected documents for independent review

- Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

Other activities:

- May support feasibility and/or site identification activities

- May negotiate clinical agreements and budgets

- Contribute to other areas of business as required

Requirements
To be successful you will possess:

- Bachelor’s degree in life sciences, healthcare, or a related biological discipline, or an equivalent combination of education, training, and relevant experience. Minimum of 3 years of experience in drug development and/or clinical research. For Senior-level roles, a minimum of 5 years of experience in drug development and/or clinical research is required.

- Minimum 2 years of experience in a similar role, or an equivalent combination of education, training, and experience in the CRO/Pharma industry. For senior-level roles, a minimum of 4 years of experience is required.

- Fundamental knowledge of GxP, privacy legislation (GDPR and/or HIPPA), and applicable local regulatory requirements preferred

- Fundamental knowledge of the country or region competent authority submission process, reporting requirements and guidelines

- Strong written and verbal communication skills including good command of English language

- Ability to work in a fast-paced challenging environment of a growing company

- Representative, outgoing and client focused

- Strong organization and time management skills

- Strong attention to detail and accuracy

- Proficiency with various computer applications such as Word, Excel, and PowerPoint required

Benefits

Disclaimers:

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC