Clinical Research Coordinator - Clinical Research

Myana; Anaheim (CA); On-site; USD 85,962,000 - 94,558,000; Full time

Job summary

CenExel Clinical Research is seeking a Clinical Research Coordinator in California to support trial coordination in accordance with ICH, GCP, protocol, and sponsor guidelines. The role emphasizes patient involvement from initiation to completion and requires meticulous data handling and regulatory compliance.

The ideal candidate will have at least 1 year of CRC experience, a high school diploma (Bachelor's preferred), and strong communication and teamwork skills for independent and collaborative

Qualifications

• 1+ year of experience as a Clinical Research Coordinator (Required)
• Phlebotomy experience (Highly Desired)
• Knowledge of Federal regulations protecting human subjects in research and GCP/ICH guidelines
• Strong leadership, mentoring, and communication skills

Responsibilities

• Coordinate all aspects of patient involvement from study initiation to study completion.
• Organize research information for clinical trials.
• Observe subjects and assist with data analysis and reporting.
• Schedule the collection of data.
• Document adverse events and protocol deviations.
• Report research data to maintain quality and compliance.
• Perform administrative and regulatory duties related to the study.
• Participate in protocol development activities.
• Ensure site receives accurate information and supplies from sponsors.

Skills

Clinical Research Coordination

Regulatory knowledge

Data collection

Communication skills

Education

Bachelor's degree preferred

High school diploma or equivalent

Job description

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.

Schedule:

Monday - Friday (08:00 am - 4:30 pm)

Hourly Range: $30.00 - $33.00 (Depending on education, experience, and skillset)

Job Summary:

Responsible for assisting with coordinating 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:

• Assists with coordinating all aspects of patient involvement 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.
• Documents adverse events, protocol deviations, and other unanticipated problems appropriately.
• 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).
• 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:

• High school graduate or equivalent; Bachelor's Degree, preferred.
• 1+ years of experience as a Clinical Research Coordinator (Required)
• Phlebotomy Experience (Highly Desired)
• 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. Rarely lift over 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.

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.