Clinical Research Coordinator

Aes; Waimanalo Beach (HI); On-site; USD 38,572 - 44,083; Full time

Job summary

CenExel Clinical Research is seeking a qualified Clinical Research Coordinator to manage patient involvement from initiation through completion. You will collaborate with sponsors, investigators, and staff to ensure protocol adherence and data integrity.

The role requires at least 1 year of CCRCs experience, strong organizational skills, and knowledge of CFR/GCP. It is an on-site position in a busy research environment with emphasis on quality and teamwork.

Qualifications

• At least 1 year of experience as a Clinical Research Coordinator.
• Knowledge of good clinical practices (GCP) as defined by CFR.
• Experience coordinating clinical trials and study visits.

Responsibilities

• Coordinate all aspects of patient involvement from study initiation to completion.
• Assist in study start-up activities and staff trainings.
• Ensure timely data entry and regulatory documentation.

Skills

Clinical Research Coordinator

Neurology experience

GCP CFR knowledge

Organizational skills

Interpersonal skills

Self-management

IRB procedures

Phlebotomy

ECGs

IRB portals

Communication with sponsors

Education

CCRC certification

Tools

Excel

Word

WIRB

Advarra

Job description

About Us

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

Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH, GCP, protocol, and company guidelines, regulations, and policies.

Essential Responsibilities and Duties

• Coordinating all aspects of patient involvement from study initiation until study completion
• Study start‑up:
  • assist in the creation of thorough and accurate source documents
  • work collaboratively with other internal departments, sponsors and investigators to ensure protocols are understood and assist in the trainings of staff members
  • participate in IMs and SIVs; communicating with sponsors and representatives
  • ensure site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)
• Screening participants for actively enrolling studies:
  • assist in reviewing all participant history from Pre‑Enrollment and Enrollment departments confirming information with potential participant and study physician
  • educate potential participants and caregivers on protocol specific details and expectations
  • work with the physician to address all questions and concerns related to the trial and informed consent process
  • maintain thorough knowledge of study specific inclusion/exclusion criteria
• Coordinating scheduled visits and adhering to protocol visit windows and timelines:
  • perform or follow up on safety and efficacy assessments per protocol: vital signs, EKGs, blood draws and other assessments as assigned
  • collaborate with the research pharmacist to perform drug accountability and compliance at each visit and educate subject on proper dosing regimen
  • accurate and timely completion of source documents recording subject’s participation in study
  • communicate closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines
  • assist investigators in collection of information from study subjects regarding AEs, concomitant medications and other changes throughout participation
  • responsible for subject scheduling, in coordination with Recruiting
  • responsible for timely data entry and query resolution
  • timely reporting of study events (SAEs, protocol deviations, etc) to appropriate departments and other outside agencies (Sponsors, CRO’s, etc.)
  • follow subjects through study completion and create follow‑up care plan with physician, study subject and primary care provider
• Ensure preparation for and facilitate all study monitoring visits and follow up promptly with monitor follow‑up letters
• prompt and professional communication with sponsors, representatives and other study related parties
• maintain professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and staff members
• keep management informed of study status and any study‑related issues
• assume other duties and responsibilities as assigned

Education/Experience/Skills

• at least 1 year of experience working as a Clinical Research Coordinator
• CCRC certification not required, but preferred
• experience in neurology not required, but preferred
• knowledge of "good clinical practices" for clinical research as defined by the Code of Federal Regulations (CFR)
• demonstrate organizational skills to efficiently and effectively manage multiple clinical trials while providing accurate information in a timely manner
• communicate and work effectively with a diverse team of professionals
• phlebotomy and ECGs experience not required, but preferred
• knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc.
• demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner
• must be self‑directed and be able to manage multiple projects and responsibilities
• computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately and experience with various EDC platforms
• experience with IRB portals, such as WIRB and Advarra preferred
• a critical thinker with strong attention to detail and superb problem‑solving abilities

Compensation

$28-32 per hour. Application window will close on June 25th, 2024.

Working Conditions

Indoor, office environment. 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.

Equal Opportunity Employer

CenExel 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 status, or disability.