About Pharm-Olam:

Pharm-Olam, LLC 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.

Summary:

Typically under the direction of a COM/CRM, the Local Site Activation Officer is responsible for assisting in all related site activation activities at a local level, especially focusing in on ED/IRB submissions/requirements and leading start up activities. 

The Local Site Activation Officer can use different tools in CTMS during the Site Activation Lifecycle and will be responsible in assisting to keep the Site Activation Milestones on track during the course of the study(s) therereby ensuring that expectations are met while identifying and mitigating the start up risks.

This is a full-time, direct hire opportunity for an Experienced Site Activation Professional, located in North America (US/Canada). SSU/Site Activation - Regulatory/IRB Submission experience is required. 

Essential Document collection activities: Submission of Essential Documents for an Investigator site and authorization for the shipment of Investigational Product to the sites

Key Responsibilities:

• Assist in preparing the Site Specific Essential Document Package and sending to sites
• Responsible for collection and first review of Essential Documents
• Responsible to provide the Global Essential Document Reviewer with the collected documents for independent review
• Responsible to follow up with the sites all the discrepancies noted by the Global Essential Document Reviewer until resolution to authorize the shipment of Investigational Product to the site

Independent Ethics Committee (IEC)/ Independent Review Board (IRB) submission/approval activities

Key Responsibilities:

• Assist the GRM in the preparation, compilation, submission and maintenance of ethical requirements documentation required by Independent Ethics Committee (IEC)/ Independent Review Board (IRB) for clinical trials and marketing applications at local level
• Assist in preparing, compiling and submitting regulatory documentation:
  • To local Independent Ethics Committee (IEC)/ Independent Review Board (IRB) submission
  • Ensure relevant documents in compliance with ethical requirements, including but not limited to subject information and consent forms, patient leaflets etc., are being reviewed per local legislation and provided appropriately.
  • Assist clinical consultants where necessary.
  • Assist in interactions with Ethics Committee (IEC)/ Independent Review Board (IRB)
• Access to Ethics Committee (IEC)/ Independent Review Board (IRB) websites/plataforms and/or contact Ethics Committee (IEC)/ Independent Review Board (IRB) at regular intervals for updates on regulations, guidelines and procedures. Ensure these changes and updates are communicated and circulated as appropriate.
• Assist in preparing, compiling answers for questions raised by the Ethics Committee (IEC)/ Independent Review Board (IRB) and submit the answers

Regulatory Authority (RA) submission/approval activities

Key Responsibilities:

• Assist the Global Regulatory Manager (GRM) in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials and marketing applications at local level
• Assist in preparing, compiling and submitting regulatory documentation:
• Assist in the preparation of local clinical trial applications.
• Ensure relevant documents in compliance with local regulation, including but not limited to clinical trial applications, study drug labels, study drug related documentation, etc. are being provided appropriately.
• Review technical, pre-clinical and clinical reports for regulatory submissions.
• Assist regulatory and clinical consultants where necessary.
• Compliance review of SmPCs and review of product labels.
• Assist in interactions with regulatory authorities
• Access regulatory agency websites and/or contact regulatory authority at regular intervals for updates on regulations, guidelines and procedures. Ensure these changes and updates are communicated and circulated as appropriate.
• Assist in preparing, compiling answers for questions raised by the Regulatory Agency and submit the answers.

Working relationships:

• Report directly to COM/CRM
• Collaborate with the GSAM/PM/CTL/ GRM
• Collaborate with the Global Essential Document Reviever
• Collaborate with Clinical Research Associates
• Collaborate with Clinical Trial Administrators, Support Services and Quality Assurance personnel
• Collaborate with local office management and Information Technology
• Liaise with Ethics Committee (IEC)/ Independent Review Board (IRB) websites/plataforms and/or contact Ethics Committee (IEC)/
• Collaborate with Quality Assurance
• Collaborate with local office management and Information Technology
• Liaise with national regulatory agencies and competent authorities

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution
• More than 2 years of experience maintaining project documentation specific to essential documents, collection and review per ICH/GCP requirements prior to Investigational Product release to the sites in the pharmaceutical or biotechnology industry
• More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry, preferily working with IEC/IRB.
• A thorough knowledge of European and CEE Ethics Committee (IEC)/ Independent Review Board (IRB) and reporting requirements and guidelines.
• A thorough understanding of the drug development process.
• Good oral and written communications skills.
• Attention to detail.
• Able to perform well as a team member.

For Consideration

Please apply online at www.pharm-olam.com/careers

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.