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Job Info –

Summary:

To ensure 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). May be responsible for assisting the RA Department in the preparation, compilation, submission and maintenance of regulatory documentation required by international regulatory agencies for clinical trials and marketing applications.
Responsibilities:

• Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
• Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.
• Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies.
• Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
• Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
• Collect and review regulatory documents as required.
• Prepare site visit and telephone reports.
• Responsible for multiple projects and must work both independently and in a team environment.
• May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
• Resolve site issues and determine status for IP shipment.
• Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.
• May translate, coordinate translations or review completed translations of critical documents.
• Participate in feasibility and/or site identification activities.
• Assist the Project Team with the day-to-day management of clinical studies as required.
• Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
• Train, mentor and/or supervise junior staff.
• May be assigned as LCRA to a regional or global study.
• May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
• Conducts project co-monitoring, assessment visits and team training.
• Site contact for protocol clarifications and subject enrolment if CRA unavailable.
• Participate in the development of study newsletters communication as required.
• Assist with the development of project-specific training materials for team.
• Liaise with Business Development and make presentations to potential clients as required.
• May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).

Working Relationship:

• Reports to the Clinical Team Leader, Clinical Research Manager or Clinical Operations Manager as appropriate.
• Collaborates with the CTLs, LCRAs and PMs as needed.
• Liaises with clients as requested by the PM.
• Liaises with national regulatory agencies and competent authorities.

Qualifications:

• At least 4 years experience.
• Skills to mentor and train other CRAs in a positive and effective manner.
• In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
• Ability to travel for 3 to 5 days on site per month, depending on the project needs.
• Strong therapeutic background.
• Can demonstrate experience and knowledge in the CRO industry that will support Pharm-Olam’s management of clinical trials.
• Has shown ability to successfully manage people/project issues.
• Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
• Demonstrates the ability to define and meet project requirements.
• Can demonstrate flexibility for improvement and creating solutions.
• Proven organizational abilities, and excellent written and oral communication and presentation skills.
• Excellent team player with team building skills.
• Strong customer focus.
• A thorough knowledge of regulatory submission and reporting requirements and guidelines.
• Excellent understanding of the drug development process.