Clinical Trial Associate

Pharm-Olam International Houston, TX
Overview

About Pharm-Olam International:

Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today's emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

Acts as the primary administrative support to local Pharm-Olam clinical study teams, as required by Project Managers and Sponsors, thus ensuring that the clinical trial is conducted in accordance with international and local regulatory and ethic laws, ICH Guidelines for Good Clinical Practice and Standard Operating Procedures. Assists the local study team with the day-to-day conduct of international clinical studies with the guidance of an experienced team member.

Note: Some responsibilities related to TMF maintenance will vary according to the study specific TMF processes. Responsibilities related to collection of critical documents may be delegated to a country-specific start-up or regulatory group, as applicable.

Responsibilities

* Provides continuous support to CRAs with the day-to-day administration of clinical studies.

* Prepares and distributes Investigator Site Files (ISFs), Pharmacy Site Files (PSFs) or other files needed for Site Initiation Visits (SIVs).

* Prepares and maintains Trial Master File (CMF and IFs) according to Pharm-Olam SOPs or Sponsor SOP, as required.

* Reviews study files periodically for accuracy and completeness.

* Prepares and maintains QC/Inventory Checklists for the TMF (CMF and IFs) and ISFs.

* Assists CRA in the QC of TMF (CMF and IFs).

* Maintains Public Folders/ePOI/S drive in accordance with the Filing Plan.

* Assists CRAs with collection and tracking of critical documents.

* Prepares and maintains country and sites related study trackers, as needed

* Assists CRAs with preparation of the Essential Document Packages (EDP).

* Performs translations and back-translations of study documentation when needed

* Performs administrative tasks to support submission process in the country, as required

* Prepares and distributes clinical trial supplies to the investigational sites and maintains tracking information.

* May communicate with local non-lab and non-IP related vendors (printing companies, translators, couriers) to obtain quotes and provide information to the CRA for obtaining approval from PM/CTL prior to placing orders.

* If needed, provides local support for organization of Investigator Meeting or any other study meeting organized in the country where CTA is located and coordinates with the hotel staff to ensure smooth running of the meeting.

* Accurately updates and maintains CTMS or other clinical systems within project timelines.

* As needed, communicates with sites regarding trial start-up, conduct, and close-out administrative and logistical activities.

* At the study end prepares TMF (CMF and IFs) for sending to Sponsor and follows up with the recipient for Confirmation of Receipt.

* Performs any other administrative tasks not listed above to support team members with clinical trial execution, as required.

* May participate in feasibility and/or site identification activities.

Working Relationship:

* Reports to Clinical Trial Associate Line Manager, COM or designee.

* Collaborates with project teams and all Pharm-Olam staff.

Qualifications

* Fluency in English (spoken and written)

* Strong verbal and written communication skills

* Computer literacy, proficiency in Microsoft Office

* Excellent interpersonal and organizational skills

* Ability to work independently and to effectively prioritize tasks

* Ability to manage multiple projects

* Attention to detail

* Ability to establish and maintain effective working relationships with co-workers, managers, investigational site personnel and local vendors.