Senior Clinical Research Associate

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 Catalyst Clinical Research LLC’s applicable SOPs and working practices.

You will be involved in reputed company stages of clinical trials, including the identification of an investigational site and evaluating, initiating, monitoring and closing out a trial. The Sr. CRA 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. The Sr. CRA will ensure the rights and safety of human subjects involved in a clinical study are protected at reputed company times.

The Sr. CRA may assume Clinical Trial reputed company responsibilities.

Position Responsibilities/Accountabilities:

• Monitor clinical trials according to monitoring plans to reputed company project goals; conduct

  or assist with site evaluations, study  initiations, routine monitoring and site reputed company-

  outs, and complete visit reputed company documentation reputed company 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 reputed company enrollment plans in

  conjunction with site staff.

• reputed company 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.

• reputed company 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 reputed company 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 reputed company 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 reputed company.

• 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 reputed company 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 reputed company of contact for a client for CRA responsibilities and study reputed company

   tasks.

• May reputed company monitoring tools and forms.

• 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, reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company timely and sound decisions.

• Ability and willingness to travel up to 70%, as needed.