PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
This role is part of Accelerated Enrollment Solutions (AES), a business unit of PPD that offers both sponsors and contract research organizations best-in-class clinical trial research site and patient enrollment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.
As a Clinical Research Coordinator you will be a key member impacting the development and research for therapeutics for patients.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.
Conducts at least one ongoing clinical trial that may involve patients or healthy volunteers. Interacts with the research site team and interdepartmental staff to ensure positive interactions with patients at site for study planning, from initiation to closeout.
- Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
- Provides medical care to patients, always ensuring patient safety comes first. Performs all defined study activities (i.e, informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG’s, etc.).
- Records all patient information and results from tests as per protocol on required forms.
- Where required, may complete IP accountability logs and associated information.
- Reports suspected non-compliance to relevant site staff.
- Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
- Promotes the company and builds a positive relationship with patients to ensure retention.
- Attends site initiation meetings and all other relevant meetings to receive training on protocol.
- May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
- Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
- Gathers source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
- Adheres to company COP/SCOP.
- May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
Education and Experience:
Bachelor’s degree or equivalent and relevant formal academic / vocational qualification in the clinical /medical field
BLS certificate required
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’)
Knowledge, Skills and Abilities:
- Basic understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
- Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
- Demonstrated ability to exercise discretion and sound judgement
- Adequate decision-making, negotiation and influencing skills
- Decent communication skills and English fluency will be an advantage
- Decent organizational skills
- Essential proficiency in basic computer applications
- Decent interpersonal skills to work in a team environment
PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves.
Occasional travel, may be domestic or international.
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
Ability to perform under stress.
Ability to multi-task.
Regular and consistent attendance.
PPD Defining Principles:
We have a strong will to win – We earn our customer’s trust – We are gamechangers – We do the right thing – We are one PPD –
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you!
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.