Clinical Research Coordinator
Vitalis Consulting LLC Monroe, NJ
- Posted: over a month ago
- $70,000 to $80,000 Yearly
- Benefits: medical, vision, dental,
CLINICAL RESEARCH COORDINATOR
The Clinical Research Coordinator will report to the Clinical Research Manager.
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire team, sponsors, and monitors to ensure productivity and timely completion of studies.
Responsibilities and Duties
- Serves as primary/secondary contact with research participants, sponsors, and regulatory Coordinates studies from start-up through close-out.
- Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol as well as ensuring they adhere to the study’s rules
- Collects and manages timely patient and laboratory data for clinical research projects ensuring essential documentation, entry, and reporting in both sponsor CRF and eCRF and company databases
- Interacts with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct
- Manages research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms
- Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
- Ensures compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents
- Assembles study kits for study visits, makes sure all equipment and supplies needed for the study are in-stock and in good working order, monitors scheduling of procedures and charges, coordinates documents, attends monitoring meetings with sponsors, acting as primary or secondary contact and participates in regulatory audits
- Develops accurate source materials and ensures compliance from site staff
- Maintains research records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA
- Supports the regulatory staff in the maintenance of regulatory documents in accordance with SOP and applicable regulations from study start-up to close out
- Ensures compliance with research protocols by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability
- Disburses investigational drug and provides patient teaching regarding administration, as necessary. Communicates and collaborates w/ study team, including internal and external parties, sponsors, PI, and study participants.
- Perform technical duties ie. Venipuncture, ECG, vitals, collecting, processing, labeling, storage and transport of blood and urine specimens etc
- Reports AE’s and SAE’s
- Adhere to Good Clinical Practice and SOP’s
- Participate in QA activities for monitor visits, close outs and audits
- Participate w/ PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
- Assists in educating medical professionals and networks within the medical community for patient referrals
- Occasional travel to attend sponsor study training meetings as required or requested by the Principal Investigator
- No supervisory responsibilities
- Other duties as assigned
- CPR-certification required
- Candidates with a Bachelor’s degree in a scientific, health related, or business administration program, preferred
- At minimum, candidates must have at least two years of experience in a clinical research Preferred candidates will have three or more years as a clinical research professional (certification as a CCRC is desired).
- Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts
- Detail-oriented and meticulous in all aspects of work
- Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
- Must have professional demeanor and strong communication skills with the public as well as physicians/researchers
- Ability to work well independently as well as in team environment
- Strong interpersonal, customer service, and multi-tasking skills are critical
- Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
- Ability to be flexible, organized, detail-oriented and tenacious in follow-through
- Possess the ability to work well under pressure, multi-task and manage deadlines
- Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures
Vitalis Consulting LLCWhy Work Here?