Clinical Research Coordinator II

CenExel; Atlanta (GA); Sur place; USD 48 000 - 62 000; Plein temps

Avantages offerts par ce poste

Health Insurance

Dental

Vision

Long-term Disability

Short-term Disability

Life Insurance

401k

Résumé du poste

CenExel Clinical Research located in Atlanta, GA, coordinates all aspects of clinical trials from initiation through completion, ensuring strict adherence to ICH, GCP, protocol, and company policies.

The role requires a Clinical Research Coordinator I with 2–3 years of medical-field experience, HS diploma (Bachelor’s preferred), and CCRC certification preferred. The site offers comprehensive benefits, equal opportunity employment, and opportunities for training and growth.

Qualifications

• Experience as Clinical Research Coordinator I
• High school graduate or equivalent; Bachelor's 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
• Strong leadership and mentorship skills
• Ability to communicate verbally and in writing effectively

Responsabilités

• Coordinate all aspects of clinical trials from initiation to completion
• Organise research information for clinical trials
• Observe subjects and assist with data analysis and reporting
• Schedule collection of data
• Review and report adverse events and protocol deviations
• Monitor and 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
• Educate participants and caregivers on protocol specifics
• Perform safety and efficacy assessments per protocol
• Assist CTM with oversight of vendors, regulatory, recruitment, and trial outcomes
• Assist CTM in planning, processes, trainings and staff development
• Assume other duties as assigned

Connaissances

Leadership & mentorship

Communication skills

Teamwork & collaboration

Crisis management

Regulatory knowledge

Formation

High school diploma or equivalent

Bachelor’s degree preferred

CCRC certification preferred

Description du poste

CenExel ACMR
501 Fairburn Road SW
Atlanta, GA 30331, USA

Description

About Us:

Each of CenExel’s research sites specialise 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:

Responsible for coordinating all aspects of 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:

• Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.
• Organises 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.

Education/Experience/Skills:

• Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position.
• High school graduate or equivalent; Bachelors 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.

Working Conditions

• 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.

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.