Clinical Research Coordinator II

Overview

Cen Exel is a leading nationwide clinical research site and patient network serving the life sciences industry. We lead in CNS and early phase studies with 18 Centers of Excellence that deliver the right patients, at the right time, in the right place. Cen Exel partners with Bay Pine Capital Partners to advance the design and execution of clinical trials, supported by world-class PIs, patient engagement strategies, data analytics, and integrated operations that optimize the clinical trial process.

Cen Exel Clinical Research also emphasizes a positive work environment, teamwork, leadership, and work-life balance, along with competitive compensation and a generous benefits package for full-time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Insurance, and 401k.

Responsible for coordinating all aspects of clinical trials with strict adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

• Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.
• Organizes research information for clinical trials.
• Observes subjects and assists with data analysis and reporting.
• Schedules the collection of data.
• Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
• Monitors, and reports research data to maintain quality and compliance.
• Performs administrative and regulatory duties related to the study as appropriate.
• Participates in other protocol development activities.
• Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.).
• Educates potential participants and caregivers on protocol specific details and expectations.
• Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
• Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes.
• Assists the CTM in planning, creating processes, trainings and development of staff.
• 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.

• Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position.
• High school graduate or equivalent;
  Bachelor’s Degree, preferred
• CCRC certification preferred
• 2-3 years of experience in the medical field, preferred
• Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
• Strong leadership and mentorship skills.
• Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
• Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.
• Works independently as well as functioning as part of a team.
• Must be able to effectively communicate verbally and in writing.

• Indoor, Office environment.
• Shift work, depending on location.
• Essential physical requirements include sitting, typing, standing, and walking.
• Lightly active position, occasional lifting of up to 20 pounds.
• Reporting to work, as scheduled, is essential.
• Overnight travel may be required for training and/or investigative meetings.

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