As a Senior Clinical Research Associate, you will be responsible for managing clinical activities at study sites conducting studies (numerous electro cardiophysiology studies) for our client's MedTech group, as well as, fostering strong, productive relationships with colleagues within the MedTech Group. Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversee performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. You serve as a member of the clinical study team and are the liaison between the clinical study team and study site personnel for the specific clinical projects.
Tasks:
Clinical Study Site Management 95%
Other Administrative Activities 5%
Key Job Activities:
Clinical Study Site Management Tasks
• Ensure that all work related activities, and decisions embody the client's Credo Values.
• Verify safety and well being of study subjects are maintained for assigned study sites.
• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
• Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
• Accountable for study site performance, and providing high quality data according to overall project timeline.
• Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Respond to problems and assists in implementing corrective and preventive actions, if required.
• Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
• Responsible for supporting patient recruitment and retention activities.
• Perform site visits and ensure study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
• Assist with internal communication of important clinical data and events.
• Support organization of Investigator and other study training meetings, if required.
• Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
• Understand business value of clinical projects and balances overall business objectives and functional needs.
• May be involved in other tasks to support Clinical Operations and Operating Company as needed.
• Support the implementation of new clinical systems/processes.
• Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.
Administrative Tasks
• You know, understand, incorporate, and comply with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• May be asked to provide additional support to Clinical Operations staff, as needed.
Education
• A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science
Experience
• Bachelors degree with at least 4 years of relevant experience; Masters or PhD/MD/PharmD with at least 2 year of relevant experience.
• Previous clinical research experience required.
• 4 years of (medical device) monitoring or equivalent experience required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background – a plus.
Knowledge
• Requires experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and Power Point)
Additional Requirements
• Demonstrated competencies in the following areas are required:
o Leadership
o Written and verbal communications (English and Dutch required, French a plus)
o Presentation and influencing
o Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).
o Ability to travel up to 80% of time.