Clinical Research Associate/ Sr. Clinical Research Associate
The Sr. Clinical Research Associate will execute clinical trial operations from start to finish in compliance with applicable regulations, guidelines and policies for one or more clinical trials.
Duties and Responsibilities:
- Responsibilities include execution of overall operations of clinical studies including planning, management and implementation for trials that support regulatory submissions and scientific publications.
- Responsibilities may include investigator qualification, CRF development, management of clinical study sites, monitoring, study tracking, interpretation of clinical data, and other clinical activities.
- Support data management activities including database development, reviewing, querying, resolution and report generation for interim and final reporting; for presentations, publication, annual reporting or regulatory submissions.
- Manage investigational product, drug and ancillary equipment supply.
- Responsible for IRB/Ethics submissions.
- Responsible for Trial Master File, Investigator Site Files and patient records (at site and Sponsor) per Tusker Medical processes and in compliance with GCP, FDA and ICH guidelines.
- Participate in development of study plans, site training materials, and other study related procedures and processes.
- Responsible for study site training and clinical case support including proctoring procedures.
- Expected to become an expert in Tusker Medical’s technologies and therapeutic areas, as well as the relevant scientific literature.
- Represent clinical department in product development teams.
- Effectively works cross-functionally with internal and external parties to ensure study plan and progress aligns with business development strategies. Applies advanced knowledge of clinical research and GCP to develop practicable solutions to a wide variety of difficult problems.
- Ensures compliance with all department, company, and regulatory policies, procedures, standards and/or guidelines during clinical studies.
- Adheres to applicable ethical regulatory and clinical standards by participating in the creation, review and approval of departmental operating procedures.
- Other responsibilities as required or assigned by manager.
Please contact HR department for job qualification requirements.
No calls or recruiters, please.