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).
Primary Key Responsibilities:
- 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. Follows the feasibility procedures for documentation of feasibilities performed.
- 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.
- 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 organisations.
- Liaises with Quality Assurance personnel.
Education Requirements and Qualifications:
- Relevant life science medical / nursing degree or relevant degree or background preferred.
- Customer service orientation.
- Sound knowledge of medical terminology and clinical monitoring process.
- Attention to detail.
- Ability to perform travel an average of 65%, 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.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects/tasks, establish and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients.
For confidential consideration, please send CV to email@example.com