Senior Clinical Research Coordinator

Thermo Fisher Scientific • Evansville, IN

12h • Onsite

About The Position

Join us as a Sr. Clinical Research Coordinator - And play a key role in overseeing clinical site activities and ensuring high standards of patient care and data integrity.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• BLS certificate required.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’)
• Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Good decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment

Nice To Haves

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Responsibilities

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provide medical care to patients, always ensuring patient safety comes first.
• Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but are not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
• Record all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance with relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attend site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/complete information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gather and maintain source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adhere to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
• Performs clinical assessments of participants, monitors laboratory safety reports, and communicates any serious or potentially serious adverse events as per the company procedure.
• Serves as a primary point of sponsor contact for all research activities for studies assigned.
• Ensures all communications are documented and shared with the appropriate team members.
• Acts as a back-up to direct people manager. This includes but is not limited to, overseeing and assigning work to team members, scheduling, and monitoring time.
• Involved in the interview and hiring process of new team members.
• Assists in the training of new team members and provides mentoring.
• Provides input into evaluations performance reviews of team members

Benefits

• When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees