Benefits:

401(k)

401(k) matching

Dental insurance

Health insurance

Vision insurance

Job description

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

Administrative Job Duties:

· Assist Site Manager with daily function of site and performance.

· Review of lab, radiology, pathology reports for timely reporting of clinical status to the Principal Investigator and the Sponsor/CRO.

· Assist all staff with prompt reporting of all adverse events to the principal investigator, sponsor and IRB in compliance with FDA regulations and sponsor requirements.

· Review of Serious Adverse Event reports and ensure completion of report with accurate information.

· Communicate suggested changes to source documents prior to publication.

· Assist with meet and greet of monitors during their visits.

· Attend site selection visits, site initiation visits, interim monitoring visits, and close out visits.

· Assist all site staff with response and completion of outstanding items related to clinical care of patients on monitor letters.

Study Related Job Duties:

· Review of records for accurate and complete drug/device distribution and accountability records of all investigational products are maintained, and the product is stored according to requirements.

· Review of subject’s current concomitant medication list to ensure no prohibited medications are prescribed during screening and throughout participation in clinical trial.

· Review dose modification section of the protocol to ensure all dosing is appropriate and corresponds with the protocol directions.

· Communicate with the Principal Investigator and/or Medical Monitor (Sponsor) when circumstances are not specifically outlined within the protocol.

· Document all correspondence with the Principal Investigator and/or Medical Monitor (Sponsor) on patient directed care.

· Assist research team with review of all clinical care components of the study prior to initiation date to ensure complete understanding and acceptance of roles and responsibilities for clinical care of the subject.

· Manage patient level activity in clinic through consent, collection of eligibility elements, and completion of source documentation.

· Collection and assessment of patient level evaluation and care through vital signs, lab assessments, and electrocardiograms.

· Coordination of care through care planning with clinicians and pharmacy staff to include infusion related requirements.

· Writing care plans/order sets for oral, injection, infusion related care regimens, to include standard of care regimens that coincide with the protocol.

· Review of the investigational product information for mechanism of action, dose instructions, rescue medications, prohibited medications, and safety follow-up once dosing is concluded.

Qualifications:

· At least 2 years of clinical experience involving patient care in a healthcare environment; no less than 1 year of clinical research experience.

· Demonstrated superior knowledge of the clinical research process.

· Demonstrate leadership skills, including ability to effectively manage patient care independently and with supervision.

· Professional and highly motivated “self-starter” with the ability to exercise initiative. Must have the ability to work as a team leader as well as independently while managing a variety of study related projects simultaneously.

· Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine.

· Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances).

· Strong written, verbal communication and interpersonal skills.

· Demonstrated ability to exercise standard Universal Precautions; in the alternative, the ability to quickly learn and apply Universal Precautions.

· Demonstrated ability to operate basic office equipment including (but not limited to) copy machines, facsimile machine, multi-line telephones and computers.

· Ability to be ambulatory most of the workday.

· Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.

· Previous training and experience in clinical research, Good Clinical Practice Guidelines and all applicable FDA regulations.

· Demonstrated ability to work with IRB submissions and correspondence.

· Demonstrated excellence in performance of the standard operating procedures.

· Critical thinking, analytical, mathematical skills.

· Regular and predictable attendance is an essential function.

Job Type: Full-time