Coordinator, Clinical Research

POSITION SUMMARY:

The Clinical Research Coordinator position is responsible for supporting clinical research staff and managing new and ongoing clinical research activities. The position includes assisting clinical investigators and research staff to drive projects forward by interacting closely with external clinical research organizations and sponsors. The Clinical Research Coordinator will adhere to GCP, ICH, and FDA guidelines in the conduct of all study related activities.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

Provide study coordination for assigned trials as directed by the Director of Clinical Research; including data coordination and quality control of research data.

Provide back-up and support for all areas of clinical research

Complete regulatory documents for IRB submissions, annual reviews and study close-out

Ensure that all Serious Adverse Events (SAEs) are reported in a timely fashion to IRB and sponsor

Create and update Regulatory Binder for each assigned study

Conduct monitoring/audit visits

Interact/liaise with study sponsors and investigators in role of study representative

Conduct eligibility screening interviews over the phone, medical records review and/or in person

Schedule study patient appointments and make reminder calls to patients; send reminder letters and emails as appropriate

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 management and staff through meetings and tracking system; maintain related records

Create and update paper and electronic study patient records

Participate in other recruitment/retention activities as needed, including calling potential participants and occasional outreach

Attend and complete trainings, staff meetings, and in-services as required

Preform phlebotomy, EKG’s, vital signs and height measurements as instructed by protocol

Assist lab personnel with specimen processing, shipping and ordering of supplies as needed

May be asked to attend Investigator Meetings for new trials as assigned

May be asked to travel to various HBH locations

QUALIFICATIONS, KNOWLEDGE, SKILL REQUIRED:

(Minimum education and experience needed to perform the job adequately)

Required:

B.S. or B.A. & 2 years+ clinical research experience

A.A. or A.S. & 5 years+ clinical research experience

High School Diploma/Equivalent & 8 years+ clinical research experience

Strong writing skills and the ability to write clearly

Strong organizational and communication skills

Strong attention to detail, ability to take initiative

Possess the ability to prioritize while multi-tasking in a team setting or alone

Working knowledge of general medical terminology

Working knowledge industry regulations, standards and guidance

Effectively communicate with physicians, nurses, pharmaceutical companies and other team members.

Preferred:

B.S. Degree in Health Care Field or Life Science

Certified Clinical Research Coordinator

 

EQUAL OPPORTUNITY STATEMENT: Decisions and criteria governing the employment relationship with all employees at Howard Brown are made in a non-discriminatory manner, without regard to race, color, creed, religion, national origin, sex, marital status, pregnancy, disability, sexual orientation, gender identity, veteran status, age, FMLA status, or any other factor determined to be unlawful by federal, state or local statutes.

HOW TO APPLY:
To apply for this position, please start the application process using the link below.  Applicants should submit both their cover letter and resume into our ADP system for consideration.

Click here to apply!

 

 

Tags: Research

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