Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Stage Clinical and Phase I IV Clinical Research services. We welcome individuals who want to be part of our growing organization. QPS is an innovative, dynamic organization that strives to employ talented, caring and committed employees who will work collaboratively towards achieving our mission of improving human health and the quality of life. QPS offers challenging and rewarding work in its four core business areas and support functions. Underpinning the operation is a culture that values diversity, innovation and accountability. Employees are encouraged to take responsibility and achieve their best, both as individuals and as team members.

Description:

The Clinical Research Coordinator’s Assistant is responsible for assisting the Clinical Research Coordinator and the Department Director with various tasks related to each study. This position is accountable for drafting study specific documents, Informed Consent Forms per the Code of Federal Regulations and the International Conference of Harmonization’s Good Clinical Practice Guidelines, study specific source and screening documents, along with enrollment and adverse event logs. Following the end of the trial, the Clinical Research Coordinator’s Assistant will also draft study closeout documentation.

Responsibilities:

Study Documents:

Drafts the Informed Consent Forms (ICFs) per the Code of Federal Regulations and the International Conference of Harmonization’s Good Clinical Practice Guidelines to ensure that all pertinent information is captured in the Informed Consent Form and that this document is written at a suitable reading level for the participants.
Drafts study specific source documents.
Drafts screening, enrollment and adverse event logs.
Drafts the Clinical Summary, Summary to the Bio-Kinetic Clinical Applications’ IRB, the IRB Closeout Letter and the Closeout Letter to the sponsor from the Vice President after study completion.
After review of the Clinical Summary, Summary to the Bio-Kinetic Clinical Applications’ IRB, the IRB Closeout Letter and the Closeout Letter to the sponsor by the Research Coordinator Director, Principal Investigator, General Manager and Vice President, obtains the appropriate signatures.

Communication:

Attends protocol training sessions. This includes Initiation Visits held by the sponsor.
Communicates information regarding participants’ visits to the staff at Bio-Kinetic Clinical Applications.
Communicates positively with study participants to collect the needed data.

Study Conduct:

Reviews time and event schedules based upon timelines specified in protocol.
Assists in protocol specific study procedures including dosing, ECGs, obtaining vital sign and height and weight measurements, BMI calculations, elbow breadth measurements, breath alcohol tests, sample processing, and administering questionnaires and tests to the participants.
Review complete screening packets including medical history, inclusion/exclusion criteria, concomitant medications, physical examinations, vital sign measurements, ECGs, height, weight and laboratory results to ensure potential participants meet the eligibility requirements of the protocol.
Prepares for study visits by setting up the clinic, making sure the appropriate equipment is readily available and preparing packets for the subjects, if appropriate.
Collect and discuss adverse events with participants ensuring that participant safety is priority.
Reviews adverse events and other source documents after completion.

Qualifications:

Combination of relevant education & experience that provides sufficient knowledge & skills to ensure incumbent’s success in this role, such as:
- Bachelor’s degree in biology, chemistry or related major is preferred
- Knowledge of Microsoft Office
- Flexible and open attitude with analytical thinking ability
- Excellent organizational and multi-tasking skills
- Excellent written and oral communication and interpersonal skills
- Experience reading and understanding SOP’s
- Knowledge about the clinical research process, including good clinical practices, informed consent process, drug accountability procedures, and IRB submission and reporting helpful

Do you have strong interpersonal skills? Are you detailed-oriented? Do you have excellent communication skills, including the ability to decipher complex written and verbal instructions? Are you attentive to detail? Are you organized and able to effectively prioritize and delegate multiple tasks? Can you meet deadlines with high-quality work? If so, you might just be perfect for this Clinical Research Coordinator position!

PHARMACEUTICAL CLINICAL TRIAL WORK SCHEDULE

This full time position coordinating pharmaceutical clinical trials primarily works Monday - Friday, 8:00 AM - 5:00 PM, but the schedule is flexible and exact hours are dictated by study activity and could include a few hours on weekends.

READY TO JOIN OUR TEAM?

We understand your time is valuable and that is why we have a very quick and easy application process. If you feel that you would be right for this job coordinating clinical trials, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you!

EEO Minorities/Females/Protected Veterans/Disabled

QPS is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. QPS prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. QPS conforms to the spirit as well as to the letter of all applicable laws and regulations.

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Clinical Research Coordinator Assistant