Clinical Research Associate
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Responsible for the co-ordination and monitoring of all clinical aspects of clinical studies. Provides a more experienced level of support to the activities of the project team. Interacts on behalf of ApoPharma Inc. with the Clinical Investigators, Contract Research Organisations (CROs), Contract Research Laboratories (CRLs) to ensure the quality of data meets the high standards specified in the Good Clinical Practices (GCP) guidelines and corporate Standard Operating Procedures (SOPs). Facilitates internal audit. Responsible for ensuring compliance with study protocol and the validity of data generated in clinical trials. Assist in the development and review of ApoPharma SOPs and reports including but not limited to clinical reports, monitoring reports and project progress reports.
- Conduct duties following established ApoPharma Inc., Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines and ICH GCP
- Acts as the principle source of communication between the Study Sponsor, Clinical Investigators, CRLs and CROs
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- All other duties as assigned.
- Responsible for managing assigned clinical trials
- Contributes as a member of the Clinical group in the planning and development of clinical trials
- Assist in the development/review and management of documentation necessary for clinical trials, such as but not limited to Informed Consent Forms, Case Report Forms (CRFs), and Study Reports
- As a member of the clinical group, communicate study requirements and study progress with colleagues and management, as well as liase with other departments in ApoPharma
- Prepare, review and sign-off on study specific documentation. Monitor and manage study data in accordance to ApoPharma Standard Operating Procedures, study protocols and pertinent regulatory regulations and guidelines
- Ensure that clinical trials are initiated and conducted in full compliance with Good Clinical Practices, ApoPharma Standard Operating Procedures, and established regulatory and safety standards and that the staff at the clinical sites are trained effectively
- Assist the Clinical Data Management (CDM) in the development and review of CRFs
- Schedule and conducts regularly monitoring visits to: ensure the clinical trials are conducted in compliance with the Study Protocol, ApoPharma SOPs, and regulations and guidelines including GCP; accountability of Investigational product; determine the accuracy and completeness of the data entered on the CRFs
- Responsible for ensuring assigned clinical trials' timelines are met
- Ensures that all regulatory and corporate requirements are met as per GCP guidelines and as stated in the study protocol
- Responsible for ensuring availability of Investigational Product for all assigned clinical trials and for ensuring product is supplied to all study sites involved in assigned clinical trials
- Ensure the clinical sites are adequately supplied with the necessary clinical related materials including but not limited to CRFs and Patient Diaries, Protocols and Investigator's Brochures
- Follow the progress of assigned clinical trials and reports on the status of all assigned clinical trials to the Project Leader, Clinical Research and management on a regular basis
- Recommends the opening and closing of clinical centers when appropriate
- Collaborate with the investigator and colleagues to review and resolve data clarification forms
- Generate data clarification when necessary
- Assist in the management of CROs and CRLs
- Participate in the review of data in preparation for regulatory submissions, Clinical Reports and manuscripts for publication purposes
- Participate in the development and review of ApoPharma Clinical Standard Operating procedures
- Participate in on-going educational activities to enhance own knowledge level as well as that of other team members. Assist with more junior CRAs and Coordinators, Clinical Trial staff training, mentoring and conflict resolution
- Maintains a current awareness of the regulatory requirements and guidelines (FDA, TPD, EMA, ICH etc…) pertaining to the conduct of clinical trials
- Responsible for outlining, developing and completing performance objectives within a set time frame
- Develop and maintain a working relationship with members of other departments within ApoPharma
- Co-operate, facilitate and support the activities of QA auditors during clinical surveillance and ensure completion of follow-up activities on schedule
- Execute others duties as may be assigned by the Project Leader and management, Clinical Research
- Project(s) update and ensure the maintenance of clinical trial timelines
Please note that employment is conditional upon the successful completion of a background check.
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.
- B.Sc. in Health Sciences (or related discipline) or B.Sc. in Nursing degree
- 5 years related experience in clinical research
- Professional accreditation such as CCRA, CCRC, CCRP would be an asset
- Demonstrated through previous work experience effective time-management skills
- Knowledge of GCP and regulatory regulations
- Proven through previous work experience the ability to work with large groups of people over extended periods of time
- Good oral and written English communication skills
- Demonstrate ability to work with MS Office Products