Clinical Research Expert
We are seeking a highly skilled and experienced Clinical Research Associate to join our team. As a Senior CRA, you will play a vital role in the success of our clinical research projects.
**Key Responsibilities:**
* Prepare and conduct site selection, initiation, routine monitoring, and close-out visits.
* Act as the primary point of contact between the project team, sponsor, and site.
* Ensure that subject recruitment targets and project timelines are met at the site level.
* Perform CRF review, source document verification, drug accountability, and query resolution.
* Facilitate the flow of site documents and assist in maintaining study-specific and corporate tracking systems.
* Support Study Startup and Regulatory teams in preparation of draft regulatory and ethics committee submission packages.
* Conduct project-specific training of Investigators and prepare Investigator newsletters.
* Participate in study site audits and client onsite visits, as required.
* Monitor project timelines and patient enrollment, implementing corrective and preventive measures.
* Support junior Monitors in the query resolution process, including Central Monitoring observation.
* Coordinate safety information flow and protocol/process deviation reporting.
* Perform clinical supplies management with vendors.
* Support site contracting and payments.
* May lead project team calls on a country level.
Qualifications:
* College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience.
* At least 5 years of independent on-site monitoring experience or an equivalent experience.
* Experience in all types of monitoring visits in Phase II and/or III.
* Experience in feasibility assessment and study set-up process is preferable.
* Experience in Oncology or Hematology therapeutic indications is a plus.
* PC skills to be able to work with MS Word, Excel, and PowerPoint.
* Ability to plan, multitask, and work in a dynamic team environment.
* Communication, collaboration, and problem-solving skills.
* Ability to travel.
What You'll Get:
* Competitive salary.
* Hybrid work arrangement - 2 days flexi and 3 days in office.
* Access to a wide range of employee benefits.
* Additional 5 days of wellness leave.
* Development and learning opportunities.
* Chance to make a real impact in a meaningful industry.
About Us:
We are a passionate, organically grown, and award-winning full-service CRO who dares to be different. As a dynamic and global company, we bring together more than 3000 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives.
Growth Opportunities:
We pride ourselves on being approachable, receptive to new ideas, and open to feedback. Our professionals have a variety of opportunities to continue to grow throughout their career from entry-level team members to senior leaders.