Clinical Research Coordinator
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.
Preparation of all study documentation such as protocols, amendments, case report forms, SAE reports and study reports are an integral part of this job. 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 Clinical Research Manager; including data coordination and quality control of research data.
- Provide back-up and support for all areas of clinical research
- Complete regulatory paperwork 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
- Assist with monitoring visits
- Interact/liaise with study sponsors and investigators in role of study representative
- Conduct eligibility screening interviews over the phone 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 trainings, staff meetings, and in-services as required
- Assist lab personnel with specimen processing and shipping as needed
- May be asked to attend Investigator Meetings for new trials as assigned
- Offices are shared for optimization of space.
- Occasional evening or weekend hours, as needed.ADA REQUIREMENTS:
- Ability to effectively communicate both verbally and written
- Ability to remain seated for extended periods of time
QUALIFICATIONS, SKILLS AND ABILITIES:
- 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.
To apply, please visit the Howard Brown Health website.