Clinical trial coordinator job description

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, helping to deliver projects to the benefit of the patients we serve.

Parexel currently has Home Based Project Leadership opportunities at levels to fit your experience and career goals.
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You will oversee all elements of the trial to ensure project deliverables and client satisfaction are executed to the highest standards. You will actively lead cross functional Parexel and client teams by combining deep clinical research experience with insight into client pressures to develop the right solutions for the clients. Your experience running global clinical trials across all phases will help you achieve operational excellence through on time and on budget delivery to the highest quality. As member of the Project Leadership team, your goal is to exceed client expectations, and help your team achieve success by serving as a role model and coach.

The Global Project Leadership department has dedicated members at all levels who are aligned to work with specific types of clients and deliver solutions customized to fit those client’s needs, working on projects spanning across all phases of global clinical trials, in a wide array of therapeutic areas.
Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with a minimum, 2+ years' experience leading Global Clinical Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director and Project Director.

To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member’s growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination

#LI-REMOTE

Title: Clinical Trial Protocol Coordinator

Location: Boston, MA

Start Date: ASAP!!

Duration: 8 - 10 months Contract to Hire

Hours: Mon-Fri; 8am-4:30pm (flexible on little earlier start or little later start)

Responsibilities

· Advise sites on protocol conduct, interpretation of protocols and ensures resolution of issues as applicable.

· Evaluate the quality of data, issue, track and resolve queries, implement corrective action plans

· Prepare presentation materials for meetings (internal/external)

· Update and maintain internal databases, tracking systems and project plans with dept./trial specific information

Requirements:

+ BS degree in Life Sciences or related

+ 1-2 yrs. research exp. in a Pharma, CRO, Biotech and/or Healthcare setting (Co-Op & Internship exp. would count towards this)

+ Excellent MS Office products exp./knowledge

+ Familiarity with EDC, CTMS systems and Adobe Acrobat applications "preferred" but not required.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Responsibilities

Under the direction of Principal Investigator, you will function as a Clinical Trials Study Coordinator in the Department of Surgery

/Division of Plastic and Reconstructive Surgery. In this role, your primary responsibility is to serve as Study Coordinator and Data

Manager for clinical trials by assuring compliance with all aspects of individual studies. As our Study Coordinator, you will be responsible for ensuring that protocol procedures have been completed accurately, safely, and in a timely manner. This includes the responsibility for research assessment and patient intervention under the supervision of the Principal Investigator (PI). All relevant IRB, regulatory and Good Clinical Practice (GCP) guidelines must be adhered to in addition to ensuring the timely coordination and completion of study related procedures for which the coordinator is responsible.Qualifications

+ Demonstrated clinical research experience, with basic knowledge of subject matter, including working knowledge of good clinical practices for clinical research.

+ Ability to work in more than one environment, travels to participating hospitals, and attend off site staff meetings, conferences, and investigator meetings.

+ Ability to work efficiently and complete tasks with a high degree of accuracy.

+ Demonstrated organizational skills to handle multiple clinical research projects for efficiency and cost-effectiveness, including handling work delegated by more than one individual.

+ Experience in performing evaluations and interventions under the direction of the Principal Investigator with Plastic

+ Surgery patients using strong clinical Judgment.

+ Excellent English verbal and writing communication skills to convey and obtain information to and from investigators, patients, families, sponsors and co-workers.

+ Effective interpersonal skills to interact professionally and diplomatically with patients, families, sponsors, co-workers, investigators, and others.

+ Under minimal supervision, ability to prioritize workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work.

+ Problem solving skill to work effectively, meet research goals, with minimal supervision.

Skill in preparation of accurate and timely annual reports and statistical information on all protocols, as needed.

Ability to work cooperatively, collaboratively, enthusiastically, as a problem solver and team player.

Minimum of one year experience in area of clinical research.

Knowledge of the UCLA School of Medicine and hospital patient care processes.

Experience with maintaining clinical trial case report forms and proper reports based on study guidelines.

Ability to work flexible hours and travel between department clinics and research sites, as needed.

UCLA is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.

UCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person's unique achievements and experiences to further set us apart.