.Why Pharm-Olam: Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach.
We strive 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 is committed to maintaining and strengthening our presence.
We offer a unique working environment with a global team culture, competitive salary, and benefits package.
This is Important Work: Ensures that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).
Your Role: Performs Selection, Initiation, Monitoring, and Closure Visits at Investigator Sites according to project schedule.
Adheres to project guidelines and Pharm-Olam SOPs for monitoring requirements.
Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
Collects and reviews regulatory documents as required.
Prepares site visit reports and telephone contact reports.
May participate in the start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, and developing study documents.
Resolves site issues, including site recruitment challenges and determines status for IP shipment.
Works with Project Manager (PM), Clinical Team Leader and/or LCRA (CTL/LCRA), regulatory team members or sponsors to secure authorization of regulatory documents and site contracts.
Informs team members of completion of regulatory and contractual documents for individual sites.
Attends Investigator Meetings (IM) and study specific training meetings.
May translate, coordinate translations or review completed translations of critical documents.
May participate in feasibility and/or site identification activities.
Contact local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation.
Performs internal in-house monitoring tasks.
Prepares and attends an Assessment Visit with a more senior CRA, Clinical Team Leader or Clinical Research Manager as required.
Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings.
Your Team: Reports directly to Clinical Team Leader, Clinical Research Manager or Clinical Operations Manager.
Collaborates with Pharm-Olam project team members.
Collaborates with Pharm-Olam and local support personnel.
Liaisons with Investigators, Site Staff, Regulatory Authorities, and Ethics Committees.
Liaisons with Sponsor scientific and medical personnel.
Liaisons with Vendors and Sub-contractors such as Central Laboratory and Courier organizations.
Liaisons with Quality Assurance personnel.
Required Education and Qualifications: Relevant life science medical/nursing degree or relevant degree or background preferred