Clinical Research Coordinator
Medical Research Of Arizona A Division Of Allergy,
Young , AZ 85554
Posted 2 weeks ago
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Clinical Research Coordinator
Medical Research of Arizona a division of Allergy, Asthma and Immunology has been serving their community for over 20 years in sponsor supported clinical trials in the area of allergy, asthma and immunology. Medical Research of Arizona is now looking to add a Clinical Research Coordinator to their dedicated research team.
The Clinical Research Coordinator position is responsible for supporting clinical research staff and conducting clinical research trials in all stages. The coordinator would be responsible for the motivation and directional drive of the protocol and recruitment of study participants. Exceptional skill set for professional communication and interaction with the clinical research team including external team members such as study participants, CRO, Sponsors and Vendors.
Duties and Responsibilities:
- Must adhere to the GCP, ICH and FDA regulations and guidelines in the conduct of clinical trials and all study related activities.
- Provide study coordination for assigned trials as directed by the Principal Investigator.
- Provide back-up and team support for all areas of clinical research.
- Ensure that all Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADR) are reported in a timely fashion to IRB and sponsor.
- Oversee the Regulatory Specialist in IRB submissions, creating and updating the regulatory process and the scheduling of research related appointments.
- Oversee the monitoring (CRA) visits.
- Interact/liaise with study sponsors and investigators as a representative of the research team.
- Plan and lead recruitment strategies for assigned protocols and participate in general site recruitment.
- Conduct Pre-screening eligibility interviews over the phone and/or in person.
- Conduct study patient visits per protocol, including screening and follow-up visits, data collection and entry, specimen collection, and other study activities.
- Communicate clinical trial status to Principal Investigator, Sub-Investigator and research team.
- Attend trial specific trainings, and assist other staff in training.
- Phlebotomy required and assist lab personnel with specimen processing and shipping as needed.
- Possible travel may be required for Investigator Meetings.(1-3 times a year)
- Manage all aspects of study startup including but not limited to contracts, budgets and essential regulatory documents.
- Perform other duties as assigned.
Required or preferred skills:
- Able to multitask
- Detailed-oriented and organized
- Ability to self-motivate and work independently
- Ability to work closely with other coordinators on shared trial
- Excellent computer skills with Microsoft Word, Excel
- Excellent communication skills
- CPR Certified or willing to become certified
- Minimal assessment skills required including ability to draw blood, preform an ECG and vital signs
- Preferred experience or knowledge of Spirometry, peak flow meter and electronic diaries
- Current GCP and IATA certification preferred
- Current LPN, MA, CAN, CRT, RRT, or RCP preferred
- Preferred asthma, allergy and immunology background
- Minimum of 1-2 years as a Clinical Research Coordinator. Or a minimum of 2 years as a Research Coordinating Assistant in sponsored clinical trials.
*The position description above is a general concept of the duties and responsibilities of the clinical research coordinator position. Please inquire by submitting your application to discuss the position in greater detail.