Study Startup Specialist I

About the role

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.

Responsibilities

• 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.
• Reviews clinical study documentation in adherence to protocol, ensuring compliance.
• 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.

Requirements

• 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.

Qualifications

• Must have a bachelor's degree in a related field.
• Must have a valid driver’s license and reliable transportation.

Skills

• Strong organizational and time management skills.
• Excellent verbal and written communication skills.
• Ability to prioritize and manage multiple tasks simultaneously.
• Knowledge of clinical research protocols and regulations.
• Ability to work independently and as part of a team.
• Basic computer skills, including proficiency with Microsoft Office.

Benefits

CenExel Clinical Research offers a comprehensive benefits package to full-time employees after 30 days of employment, which includes:

• Health Insurance
• Dental
• Vision
• LTD (Life Insurance)
• STD (Short Term Disability)
• Life Insurance
• 401k

Pay

Competitive compensation based on experience and qualifications.

Schedule

Full-time position with flexible scheduling to accommodate clinical trial needs.

Equal Opportunity Employer

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.