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.
Ability to effectively communicate both verbally and written
Ability to remain seated for extended periods of time
EQUAL OPPORTUNITY STATEMENT:
All employment decisions at Howard Brown are made without regard to any person’s race, color, sex, gender identity, gender identity, age, religion, disability, national origin, ancestry, sexual orientation, marital status, parental status, military discharge status or source of income.
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.
Howard Brown Health is an innovative health and human service organization focusing on the gay, lesbian, bisexual and transgender community. Howard Brown provides a unique network of programs and services to the community, addressing the medical, social and research needs of its clients.