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).
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.
Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.
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, reviewing CRFs, preparing Informed Consent forms, developing study documents, and organizing and presenting at investigator meetings.
Resolves site issues, including site recruitment challenges, and determines status for IP shipment.
Assists the Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission.
Works with PM/CTL/LCRA to secure authorization of 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.
Participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed.
Identifies the documentation required for review by Regulatory Authorities and Ethical Committees. Prepare Regulatory and Ethics Committee submissions. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation.
Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required.
Conducts Assessment and/or Training Visits of CRA I/II as required.
Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings.
Organizes processes for interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with Pharm-Olam accountant, logging trial expenditure, receipts, invoices and income.
Provides secondary in-house review of CRFs (if required).
Must work both independently and in a team environment.
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.
Liaises with Investigators, Site Staff, Regulatory Authorities and Ethics Committees.
Liaises with Sponsor scientific and medical personnel.
Liaises with Vendors and Sub-contractors such as Central Laboratory and Courier organizations.
Liaises with Quality Assurance personnel.
At least three years clinical monitoring experience and/or relevant clinical trial experience.
Relevant life science degree/medical/nursing background or equivalent.
Customer service orientation.
Sound knowledge of medical terminology and clinical monitoring process.
Attention to detail.
In-depth therapeutic and protocol knowledge as provided in previous or company provided training.
Ability to perform travel an average of 70-80%, depending on project needs.
Excellent communication in English in both written and verbal skills.
Computer literate and proficient in Microsoft Office.
Excellent interpersonal and organizational skills.
Demonstrated ability to work independently and to effectively prioritize tasks.
Demonstrated ability to manage multiple projects.
Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients.
Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues.