Study Startup Specialist I

About Us:

CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:

Under moderate supervision, the Study Start Up Specialist I is responsible for initiating and implementing study start up activities for the daily operational and administrative functions of clinical study operations with a focus on project and resource management. Ensures the implementation of policies and procedures of site and regulatory agencies are met or exceeded.

Essential Responsibilities and Duties:

• Ensures that assigned start-up activities are on track and in accordance with client and internal expectations.
• Inventories, logs, and organizes study materials received during study start up.
• Distributes study materials to delegated individuals while maintaining accountability for the transfer of supplies.
• Collaborates with clinical staff to ensure that studies are conducted efficiently and are completed with the highest quality standards and outcomes.
• Communicates with external vendors including contract research organizations, sponsors and monitors on behalf of clinical staff.
• Review clinical study documentation in adherence to protocol, ensuring compliance.
• Participates in for mal training of study staff prior to first subject screening.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

• Must be able to effectively communicate verbally and in writing.
• Thorough understanding of clinical research terminology, good clinical practices, regulatory and ethical guidelines and regulations.
• One year of experience in clinical research.
• Strong customer service and client relationship skills.
• Excellent organization and time management skills with strong ability to prioritize and multi-task across competing demands.
• Excellent verbal/written communication skills with evidence of effective collaboration across businesses and functions.
• High-level computer skills.

 

Working Conditions

1. Indoor, Clinic and Office environment.
2. Essential physical requirements include sitting, typing, standing, and walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
5. On site work arrangement.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.