Spaulding is looking for an individual to join our award winning team! If you have prior clinical research coordinator experience, and are looking for an exciting new challenge this might just be the role for you. Prior phase 1 experience and certification (CRP or ACRP) is strongly desired. We are looking for experienced professionals that are looking to help us change the face of clinical research.
1 Full Time Opening
Standard hours M-F 8am-5pm
Some evening and weekend hours may be required
Flexible time and summer hours
Health, Dental, Vision, Life, Long/Short Term Disability, Supplemental Insurance options
Paid vacation and holidays
Responsible for study activities related to the conduct of clinical trials with emphasis on the safety and welfare of study participants. Perform project/study management related responsibilities by coordinating activities for Clinical Pharmacology Studies in compliance with protocol, Standard Operating Procedures (SOPs) and regulatory guidelines from the inception of the protocol throughout completion of the database lock process. This involves working closely with all functional areas as well as external providers to ensure consistent high quality study outcomes.
Essential Duties and Responsibilities:
At study award, responsible for establishing communications with the pharmaceutical sponsor, and initiating study setup.
Creates a Project Plan for the study and delegates study setup tasks to the appropriate departments and staff.
Oversees the design and development of the clinical research study, and compiles all setup items into the comprehensive operational plan directory.
Throughout the study, ensures that all study activities are executed according to the study protocol, regulatory guidelines, and operational plan.
Reviews Investigational Drug Brochures, Protocols, Case Report Forms (CRFs), and informed consent forms for a thorough understanding of the study drug and procedures.
Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
Identifies necessary study supplies and orders them through appropriate channels.
Assists with health screening, on study and follow-up of volunteers, obtains structured health and drug histories, vital signs, obtains ECGs, EEGs, lung function tests, psychometric tests, collects and processes biological specimens, assists the physicians with physical examinations.
Administers test compounds as appropriate, makes appropriate observations, collects and processes biological specimens as required by the protocol.
Maintains accurate records of all protocol activities and events, sampling times, special test procedures and adverse events.
Follows progress of volunteers and provides for their care, comfort and safety by attending to their needs during study participation.
Provides shift and weekend coverage for in-house studies and follow-up visits.
Contributes and is accountable for a secure and appropriate storage of all drug supplies.
Ensures effective verbal and written communications inter and intra departmentally in the planning and implementation of volunteer clinical research regimens.
Directs, supervises and contributes to the development of nursing and technical staff caring for the volunteers.
Participates in quality assurance of clinical research studies and initiates the need for same as it impacts on clinical practice.
Reviews professional growth plans developed by direct reports when applicable.
Participates and collaborates in the presentation of reports and abstracts research proposals while actively involved in pertinent professional organizations.
Readily accepts responsibility and is accountable for own and delegated activities.
Education and Experience:
Current RN License preferred, but not required
ACLS certification preferred, but not required
Ability to prepare for CRC certification
Prior experience in multi-level project helpful
Demonstrated knowledge of Good Clinical Practices
Who We Are:
aims to be the clinical research organization by which all others are measured. Pioneering in our approach to redefining how the industry perceives and achieves success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for our volunteers, customers and employees; and heroic in our ambitions to ensure the health and safety of people around the globe - Spaulding Clinical is taking
research beyond results
to create a marketplace of safer drugs. Here our employees are not cogs in a wheel or dollar signs on a spreadsheet. They are the innovators and creators behind the ingenious solutions and disruptive innovations that continue to propel us ahead of the pack. Come be disruptive with us!
We are an equal opportunity employer. Spaulding Clinical does not discriminate on the basis of race, religion, sexual orientation, gender identity, age, marital status, national origin, veteran status, disability, or any other basis covered by appropriate law. All aspects of employment are decided on the basis of merit, qualifications, and business need. Simply put, we celebrate diversity in all forms and have zero tolerance for discrimination, harassment, or plain hate.