Research Data Coordinator (Research Department)Apply Now
Essential Job Functions:
- Perform study-related evaluations as required by protocol and commensurate with skills and experience.
- Ensure proper subject recruitment, screening, enrollment, and scheduling.
- Recruit patients, monitor their study progress, and work closely with patients to assure visit schedule compliance.
- Participate in pre-study and site initiation planning.
- Assures accuracy and integrity of all study data in compliance with study protocol, FDA regulations, and sponsor requirements.
- Transcribes clinical data from the medical chart to the Sponsor data collection tool.
- Creates data collection and tracking forms.
- Tracks data forms, reports, and document necessary for completion of clinical study.
- Collects and manages laboratory specimen collection and shipping according to protocol and all other applicable regulations.
- Monitor subject safety through routine subject follow-up and records Adverse Events (AEs) as governed by GCPs.
- Develop study specific source document templates, forms, and tools to expedite the accurate collection of data.
- Provide recommendations for continuous process improvement and maintains working knowledge of the Research Departments Standard Operating Procedures.
- Perform other related duties as assigned.
General Job functions:
- Other job duties as required, working under the supervision of the Principal Investigators, physician leadership and the Supervisor of Clinical Research.
- Extreme temperatures
- Combative Patients / Visitors
Education, Certification, Computer and Training Requirements:
- Associate's Degree required; Bachelor's Degree preferred
- RN, LPN, MA, or equivalent with proper licensure. ACRP Certified Clinical Research Coordinator preferred. Maintain a valid CPR certification.
- 5+ years of experience working in the clinical research setting at a health care institution
- Knowledge of FDA regulations for Clinical Trials.
- Ability to follow protocol precisely, without deviation.
- Ability to effectively communicate in English, both orally and in writing.
- Must possess strong attention to detail and organizational skills.
- Ability to multi-task and prioritize workload.
- Ability to maintain confidentiality.
- Experience with Standard Office Equipment (Phone, Fax, Copy Machine, Scanner, Email/Voice Mail) required.
- Experience with Standard Office Technology in a Windows based environment.
Physical Job Requirements:
- Physical mobility, which includes movement from place to place on the job, taking distance and speed into account.
- Dexterity of hands and fingers
- Endurance (e.g. continuous typing, prolonged standing/bending, walking)
- Travel to satellite locations for meetings
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