Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Alliance for Multispecialty Research is a fast-growing clinical research organization that conduct trials for the development of pharmaceuticals.
AMR offers competitive pay, 401K matching, health/dental/vision, paid STD and LTD, as well as on demand access to your pay!
Team Member Benefits:
· Health, Dental, Vision
· Supplemental Life Coverage
· Short-term Disability and Long-term Disability (AMR covers cost)
· Life Insurance (AMR covers cost of AD&D $50,000)
· 401K (employer matching)
· Paid Time Off
· Holiday Pay
· Employee Assistance Program
Position Overview
The role of the Clinical Research Assistant is to perform a wide variety of clinical and administrative tasks to assist the clinical research coordinator in conducting clinical trials. The research assistant is responsible for study support activities to ensure each study is completed accurately, according to protocol, and on time.
To consistently embody AMR’s Core Values:
· Excellence and Consistency
· Collaborative Innovation
· Respect for our Subjects, Sponsors and Team Members
· Community
· Unimpeachable Ethics
The Clinical Research Assistant reports to the Team Lead/Site Manager/General Manager.
Classification: Non-Exempt
Primary Responsibilities:
· Assist coordinators with administrative study activities in a timely manner as necessary.
· Assist monitor during all site visits if applicable.
· Maintain accurate enrollment/drug logs if applicable.
· Assist in general office workflow which includes telephone answering.
· Responsible for assisting regulatory administration work for necessary periodic IRB reviews, both ongoing and final.
· Establish and maintain patient rapport during clinical drug trials to include management of subjects
o Clinical data collection such as vital signs, EKG recording, subject weights
o Medical record retrieval and review when required
o Subject interviews
o Phlebotomy
o Specimen collection, processing, and storage
o Complete source documentation
o Filing and pulling study records
o Transporting clinical specimens to the laboratory
o Answering and triage of research office calls
· Work with physicians and other staff to maintain a more effective and systematic method to investigate clinical problems related to the support of the clinical trial patients.
· Facilitate communication between the site and various monitors, to include telephone and written correspondence as well as monitoring visits.
· Scheduling of various visits/procedures
· Assists providers with various visits/procedures
· Perform site and protocol specific training in a timely manner
· Other duties as assigned
Additional Responsibilities (Check If Applicable):
Cross train in lab coordinator duties to serve as a backup.
Monitor patient arrivals and check-in subjects according to receptionist duties
Responsible for filing source documents in the subjects charts
Take patient history
Train subjects on diaries
Create screening charts once the screen source is available
All screening chats and randomization charts for the next day pulled
Clinic rooms and subject bathrooms are stocked including necessary medical supplies
Desired Skills and Qualifications:
· At least 6 months of past medical office experience, medical certificate, or equivalent previous work experience required.
· Phlebotomy skills preferred
· Ability to work consistently and effectively as part of a high-performance work team.
· Ability to effectively devote keen and acute attention to detail.
· Demonstrated ability to exercise standard Universal Precautions, or ability to quickly learn and apply Universal Precautions.
· Positive attitude and the ability and desire to work in a company that embraces collaboration and a team approach.
· Demonstrated ability to operate basic office equipment including (but not limited to) copy machines, facsimile machine and computers.
· Strong verbal and interpersonal skills
· Professional and highly motivated “self-starter” with the ability to exercise initiative, together with ability to work as a team player as well as independently while managing a variety of skills in a variety of software environments, i.e., Word, Excel, Internet.
· Excellent task management and prioritization skills.
· Proven ability to successfully build and cultivate excellent long-term relationships
· Excellent follow up
Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.**
Job Type: Full-time
Salary: From $18.00 per hour
Benefits:
Schedule:
Experience:
Work Location: In person
Job Type: Full-time
Pay: $23.00 - $25.00 per hour
Expected hours: 40 per week
Benefits:
Schedule:
Experience:
Work Location: In person
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