Coordinator, Clinical Research
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)
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.
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.