Clinical Research Associate, Biopharmaceuticals - Apotex - Toronto, ON

The Department of Preclinical and Clinical programs is responsible for the Planning, development and execution of clinical studies required for Biopharmaceutical product development programs. Reporting to and in consultation with the Project Leader, Preclinical and Clinical programs, Biopharmaceuticals. Responsible for the supervision of Clinical CROs in the Biopharmaceutical virtual model. Facilitate the clinical related activities for the development of new Biopharmaceutical products. To provide support and assistance to the Project Leader, Preclinical and Clinical programs, as required.

Job Responsibilities:

* Conduct duties following established Biopharmaceuticals, Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines and ICH GCP

* Performs all duties in support of the Apotex Corporate Values of Pride, Accountability, Integrity and Diligence

* Works directly with the Project Leader, Preclinical and Clinical programs in the planning, development, assignment and administration of clinical studies and supervision of external Clinical CROs.

* Establish, update and ensure the maintenance of clinical trial timeline.

* Provide input and assistance to the Project Leader, Preclinical and Clinical programs, in the areas of: maintaining the objectives of the department mission statement through training, mentoring, conflict resolution and reinforcing effective performance within the Biopharmaceuticals Division

* Collaborates in the development and or revision and implementation, of Standard Operating Procedures.

* Supports the Biostudy Project Team in the conduct/monitoring of the study and demonstrates commitment to the team construct

Relationship with Internal/External Customers & Stakeholders:

* Requests for Proposal, vendor selection recommendations, contract negotiations and feasibility assessment.

* Directly interfaces/interacts with the clinical sites Investigator, Contract Research Organizations, Clinical Research Laboratories and other departments Biopharmaceuticals. and Apotex Inc. as required

* Investigates and reports on new clinical techniques, equipment or concepts to enhance the operations of the clinical department

* With the assistance of the Project Leader, Preclinical and Clinical programs, assigns schedules and facilitates the tasks and documentation required to ensure the consistent management of all clinical trials from conception through completion and filing of the Clinical Reports. This includes but is not limited to: Identifying Contract Research Organizations (CROs), Clinical Research Laboratories (CRL) as required

* Collaborate in the preparation of: Investigator’s Brochure, Protocol, Case Report Forms, Informed Consent form, manuals and tracking forms

* Identifying Investigators and key opinion leaders

* Preparation and execution of Confidentiality Agreements

* Evaluation of clinical sites, CROs, CRLs

* Site personnel training and undertake co-monitoring visits to clinical sites

* Requesting and facilitating completion of required regulatory documents

* Contract Negotiations, if required

* Planning and execution of various clinical study related meetings which includes but is not limited to: Investigators Meeting, study site initiation, Safety and Steering Committee meetings

* Develop and maintain a working relationship with members of other departments within the Biopharmaceuticals division and Apotex Inc.

Problem Solving Analysis:

* Responsible for obtaining quotes for different assay; requesting work and cost proposals from the CROS for the assays; budgeting of the clinical trial supplies which is conducted at an external organization

* Study budget, scheduling, progress tracking and reporting

* Clinical supplies ordering

Compliance & Due Diligence:

* Ensure that clinical trials are initiated and conducted in full compliance with ICH Good Clinical Practices, Biopharmaceuticals. Standard Operating Procedures, and established regulatory and safety standards and is responsible for ensuring Investigators and their staff are trained effectively

* Follow the progress of assigned clinical trials and reports on the status of all assigned clinical trials to the Project Leader, Preclinical and Clinical programs and other departments within Biopharmaceuticals on a regular basis

* Collaborate with the Investigator and colleagues during the review process of the Clinical Data

* Schedules and conducts required Quality Control visits of CRAs, investigative sites, contract CROs to: ensure compliance with the Study Protocol and Federal Regulations including Good Clinical Practices; assess the continued adequacy of the CRA, CRO and Investigator and his/her facilities and to confirm the Investigator’s adherence to the Protocol; determine accountability of Investigational product, determine the completeness of the CRFs, the accuracy of the data entered on the CRFs as compared to Medical Records and supporting documentation

* Support in responding to regulatory letters/notices

* Assist in writing sections of the clinical report for submission and preparation of manuscripts for publication

Decision Making/Autonomy:

* Prepare, review and sign-off on study specific documentation and manage study data in accordance with Biopharmaceuticals. Standard Operating Procedures, protocols and pertinent regulatory guidelines including ICH GCP

* Assist QA personnel during QA audits of clinical trials, CROs, and CRL as required

* Schedules and conducts required Quality Control visits of CRAs, investigative sites, contract CROs to: ensure compliance with the Study Protocol and Federal Regulations including Good Clinical Practices; assess the continued adequacy of the CRA, CRO and Investigator and his/her facilities and to confirm the Investigator’s adherence to the Protocol; determine accountability of Investigational product, determine the completeness of the CRFs, the accuracy of the data entered on the CRFs as compared to Medical Records and supporting documentation

* Oversees in the management of CROs and CRLs

Leadership/Professional Development of Self & Others:

* Responsible for maintaining an awareness of Marketed and Investigational Products to understand the current and future place in therapy of the new products being develop and to contribute to the overall development plan

* Participate in on-going educational activities to enhance own knowledge level and maintain a current awareness of the ongoing changes in the pharmaceutical regulatory environment (FDA, TPP, EMA, ICH…) as they pertain primarily to the conduct of clinical trials

* Responsible for outlining, developing and completing performance objectives within a set time frame

* Execute other duties as may be assigned by the Project Leader, Manager or Director, Preclinical and Clinical Programs

Job Requirements:

* BSc in Health Sciences or related discipline

* 5 years of related experience in clinical research

* Previous experience in management of Phase III clinical trials is a requirement

* Knowledge of GCP and regulatory requirements

* Requires work schedule flexibility in order to accommodate overseas teleconferences at various times

* Strong time management skills

* Proven through previous work experience the ability to work with large groups of people over extended periods of time

* Excellent verbal and written communication skills

* Proficient in MS Office Products

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.