Clinical Research Coordinator Sr.

About Us:

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

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:

Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

Essential Responsibilities and Duties:

• Coordinates all 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.
• Oversees study protocol scheduling and collection of data.
• Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
• Manages, 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.
• Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members.
• 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 senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities.
• Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness.
• Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators.
• 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 have proper experience and demonstrate mastery of Clinical Research Coordinator II position.
• Bachelor's degree, preferred.
• CCRC certification preferred.
• 5 years of experience in the medical field or Masters Degree, 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.

Working Conditions

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

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.