Job Summary (Primary function)
The Clinical Research Associate conducts routine site monitoring visits and participates in site selection, site initiation, and study closure activities. The position ensures that the clinical trial is being conducted according to the approved protocol, amendments and in compliance with Good Clinical Practice (GCP), Company SOPs, and all applicable regulatory requirements.
Essential Functions of the Job (Key responsibilities)
Responsible for evaluation, initiation, monitoring, close-out and other tasks associated with the management of clinical sites. Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP).
Serve as primary contact for CROs/vendors, Investigators and study coordinators for study related questions.
Support feasibility and site selection process for clinical studies.
Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.).
Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
Review all AE/SAEs and ensure appropriate documentation is in place and any other safety issues are addressed and communicated.
Assist and support data validation and data cleaning procedures to ensure timelines are met.
Order and coordinate study supplies for clinical studies
Develop and maintain tracking tools to support management of clinical studies.
Plan and participate in Investigator meetings and CRA trainings.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Position requires BA/BS or RN, preferably in the Life Sciences.
Minimum of 2+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock.
Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials.
Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
Good knowledge of concepts of clinical research and drug development.
Strong working knowledge of EDC, IVR and CTMS systems.
Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information.
Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills.
Ability to travel 70-80%.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.