Clinical Research Coordinator Assistant / Madison, WI (On-Site)

Clinical Research Coordinator Assistant

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.

We are currently seeking a Clinical Research Coordinator Assistant to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment. Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.)

This is a full-time, office/clinic-based job in Madison, WI.

If you join us, you will work with some of the world’s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

Many Coordinators are drawn to their profession because of its direct impact on patient care. If this is your case, you will not miss that working in Phase 1 trials. Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, you’ll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know you’ll touch many patient’s lives around the world.

***This position is not eligible for sponsorship***

What You Will Do:

Overall accountability for the operational conduct of assigned studies, working closely with the Project Manager, Principal Investigator and operational staff and ensuring that all studies are conducted in accordance with regulatory and protocol requirements, and standard operating procedures whilst maintaining the safety and integrity of the study. The Clinical Research Coordinator is the primary site contact for the Project Manager (PM) communicating any potential issues and assists in taking appropriate action in response to these issues, ensuring that client requirements and timelines are always met or exceeded. Independently undertakes routine studies and more complex studies with guidance. May coach and mentor Operations coordinators and junior staff.

• Study Set-up – Performs all aspects of the set-up process to include the development and approval of study specific documents, study schedules and clinical procedure planning.

• Coordination - Coordinates the running of critical events, i.e. check in, PK days, check out by resolving/escalating issues identified by both staff and study participants. Monitors and maintains participant safety, dignity and compliance, including coordination of appropriate medical consultation/treatment as appropriate. Provides updates regarding study participants wellbeing to the investigators and Project Manager including adverse event updates.

• Study Meetings -Facilitates/attends and contributes to all key Study Planning meetings, i.e. Clinical Start Up Meeting, Clinical Planning Meeting, Site Initiation Meeting.

• Protocol Review – Reviews protocols, provides consolidated comments from the clinical site on the draft study protocol to the Project Manager or Medical Writer, taking into account the logistics, safety (staff and study participants), and site's capabilities. May distributes final protocols and amendments to the site.

• Study Planning – Proactively works with the site to ensure that the laboratory, equipment and all operational requirements are fulfilled and that the study is adequately resourced. Working closely with the Operations and Pharmacy to ensure dosing runs efficiently and that all documentation is completed accurately within a timely manner.

• Complaints – handles participant complaints efficiently and effectively in order to maintain customer satisfaction.

• Clients – Is aware of client expectations for trial conduct and works to meet or exceed them. Facilitates client visits, and attends client calls with the assistance of the Project Manager and/or site management where appropriate. Participates in Client and process Audits by covering study conduct questions.

• Training - Deliver/facilitate study specific training.

• Learns and develops Clinical skills to perform study tasks and performs procedures as necessary.

• Participant eligibility – verifies eligibility for Panel Selection and at Pre dose by determining whether protocol criterion has been met. Communicates with investigators and PM regarding study participant eligibility.

• Oversees maintenance of study master file ensuring that site related documents are available for uploading to the eTMF.

• Create/manage study specific shipping calendar ensuring biological samples are shipped as directed by the client in a timely manner.

• Data Monitoring – Facilitate/coordinate monitoring visits and coordinate site resolution of any comments/queries raised.

• Quality - Ensures all protocol deviations and or unscheduled events are properly documented and communicated.

• Works with site management to maintain timely completion of issues raised from CQI's and client audits, implementing new processes where necessary.

• Works with Recruitment/Screening to define a recruiting plan ensuring that the study is recruited on schedule, updating Project Manager on a regular basis.

• Consult with pharmacy staff to ensure awareness of receipt inventory, accountability and disposal of clinical trial materials.

• Assist with on time source document completion and query process.

• Authorizes study participant stipend payments as required.

• All other duties as needed or assigned.

You Need To Bring…

• University/college degree desirable (life science, pharmacy or related subject preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology).

• In lieu of a degree, typically 3 years' experience in a related field will be considered

• 1-2 years of hands-on experience supporting clinical trials in a Clinical Research Coordinator (CRC) capacity.

• Knowledge of protocol designs, study objectives and study procedures

• Knowledge of drug development process, ICH guidelines and GCP

• Previous customer service experience desirable

• Previous experience of coordinating people or processes desirable.

The important thing for us is you are comfortable working in an environment that is:

• Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even a few minutes will create a quality issue.

• Changing priorities constantly asking you to prioritize and adapt on the spot.

• Teamwork and people skills are essential for the study to run smoothly.

• Technology based. We collect our data directly into an electronic environment.

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)

• 401(K)

• Paid time off (PTO)

• Employee recognition awards

• Multiple ERG's (employee resource groups)

Physical Requirements:

• 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 to operate lab equipment.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.