Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.  

As a Senior Clinical Research Associate you will be a key member of the Development Operations, Clinical Monitoring Team. The Senior Clinical Research Associate monitors clinical trial programs and manages regional clinical trial sites to support biological and pharmaceutical developmental programs in a manner consistent with relevant global regulations along with Aptus/Catalyst Clinical Research LLC’s applicable SOPs and working practices.

You will be involved in all stages of clinical trials, including the identification of an investigational site and evaluating, initiating, monitoring and closing out a trial. You will work closely with the project team in order to ensure compliance with appropriate regulations and guidelines throughout the trial and will conduct data analysis to ensure this meets the required clinical standards. You will ensure the rights and safety of human subjects involved in a clinical study are protected at all times.

You may assume Clinical Trial Lead responsibilities.

Position Responsibilities/Accountabilities:

• Monitor clinical trials according to monitoring plans to achieve project goals; conduct or assist with site evaluations, study initiations, routine monitoring and site close-outs, and complete visit related documentation within specified company timeline.
• Work with the study start up team and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
• Assist site staff in driving patient recruitment and develop enrollment plans in conjunction with site staff.
• Perform data review activities, collaborate with data management to identify trends and implement corrective action to enhance data quality.
• Ensure study documentation is maintained in the Investigator Study File and where necessary ensure relevant documents are transferred or copied to the (electronic) Trial Master File.
• Document accountability, stability and storage conditions of clinical trial materials as required by the sponsor. Perform investigational product inventory and ensure return of unused materials to designated location/verify destruction as required.
• Effectively communicate with site study staff and Catalyst Clinical Research LLC. clinical research personnel to report study site status, disseminate information to the appropriate individuals, and resolve study related issues
• Pro-actively manage site issues and incorporate a root cause analysis and corrective action and preventive action plan.
• Coordinate with the ethics committee in order to ensure the rights, safety and well-being of all trial subjects including provision of updates according to local requirements.
• Participate in project audit/inspection preparation and conduct, as necessary, and assist with audit/inspection responses.
• Collaborate closely with the Project Manager and Clinical Trial Lead.
• Work closely with the extended study team including the Sponsor, Vendors, Data Manager(s), Statistician, Medical Monitor, and other trial staff.
• Maintain a home office if working remotely. Manage work activities in a time- and cost-effective manner to ensure budgetary guidelines and project timelines are met.
• Participate in internal and/or external meetings to maintain current knowledge on applicable regulations and guidelines.
• May provide training including but not limited to co-monitoring for new monitors regardless of their previous monitoring experience.
• May act as the point of contact for a client for CRA responsibilities and study related tasks.
• May develop monitoring tools and forms.
• May assist in the review of monitoring visit reports.
• May assist in leading CRA meetings and documenting meeting minutes.
• May assist in the preparation of study documents such as annotated visit reports and visit report templates, Clinical Monitoring Plan, cohort management plan, study specific templates, SIV training presentation, study operations manual, source data verification plan, laboratory manual and informed consents.

Managerial Requirements/ Responsibilities: N/A

Position Qualifications/Requirements:

Education: University/college degree in life sciences preferred (or the equivalent of 5-6 years industry experience, or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology, or equivalent, relevant experience.

Experience: Minimum of 5 years CRA direct monitoring experience with a sponsor company or CRO, or other related experience.

At least 2 years experience monitoring trials in oncology /heamatology

Required Certifications: N/A

Required Skills:

• Strong knowledge of Australian clinical trial regulations, as appropriate, and ICH GCP guidelines.
• Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
• Good knowledge of assigned therapeutic area.
• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Excellent presentation skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to make timely and sound decisions.
• Ability and willingness to travel up to 70%, as needed.