Clinical Research Coordinator

Hospital for Special Care•New Britain, CT

17h•Onsite

About The Position

The Clinical Research Coordinator assists the Principal Investigator (PI), Co-Investigator, and collaborating colleagues with the implementation of clinical research studies involving the health and functioning of individuals. This role involves learning and strictly adhering to research protocols approved by the Institutional Review Board. The coordinator reviews and explains informed consent procedures, extracts specific data from medical records, completes data collection interviews, and manages both written and electronic data. Responsibilities also include general clinical trials and grant management, such as grant submission, serving as the sponsor liaison, oversight of daily administrative functions, information management, financial and budgetary oversight, and protocol implementation. The position requires initiative and judgment in determining methods and procedures, and prioritizing work assignments for smooth and effective operations.

Requirements

BS in health care related field or equivalent Nursing Degree.
At least basic or entry level familiarity with personal computers and software applications for e-mail, word-processing and data management (ex. word; excel).
Excellent attention to detail, verbal skills, interpersonal skills, and the capacity for collaborative assistance with multiple staff involved in multidisciplinary research projects.
Certification in clinical research and/or clinical research trials.
Working knowledge of development and administration of clinical protocols.
Experience in health care outcome measures and data management.
Ability to work well and communicate with co-workers, peers, monitors and potential subjects to promote a team philosophy with a positive attitude.
Ability to effectively and efficiently handle multiple tasks with precision and adherence to protocol.
Strong language and interpersonal skills, a high degree of attention to detail, accuracy, and confidentiality, as well as excellent planning and organization abilities.
A high level of reading proficiency, writing, communication skills including active listening, and clear expression of both practical and complex ideas.
Learning and developing knowledge of medical terms and definitions.
Independent problem identification, abstract reasoning and adaptability.
Decision making on issues with significant organizational impact is required.
A basic understanding of research methods, the ability to follow a structured research protocol, and an appreciation of ethical issues involved in research with human subjects.
The ability to learn and master software applications for data entry and data management.
A high level of communication skill, including expression of abstract/complex ideas, use of negotiation and active listening, and an ability to dialogue with multiple parties.
Strict confidentiality of personal information collected in compliance with HIPAA regulations.

Nice To Haves

Ability to lift and/or push/pull up to 20 pounds.
Gross grasp is necessary in both hands and fine manipulation is required in the dominant hand.

Responsibilities

Assists the Principal Investigator (PI), Co-Investigator and collaborating colleagues with the implementation of clinical research studies involving the health and functioning of individuals.
Learns all research-related protocols in detail, and maintains strict adherence to the protocols as approved by the Institutional Review Board.
Reviews and explains informed consent procedures, extracts specific data from medical records following a standard protocol, completes data collection interviews with subjects either face-to-face or by telephone following standard protocols, and manages written and electronic data at Hospital for Special Care.
Responsible for general clinical trials and grant management including grant submission, sponsor liaison contact person, oversight and daily administrative functions, information management, financial and budgetary oversight, and protocol implementation.
Exercises initiative and judgement in determining the most appropriate methods and procedures to be used and prioritizes work assignments to ensure smooth and effective operations.
Supervise, manage, and coordinate clinical trials, allocating resources, setting priorities, monitoring all activities within the unit, ensuring that solutions to problems are found and implemented.
Responsible for the daily aspects of administrative functions, grants management, information management, financial and budgetary oversight, and guidance in protocol design and implementation focusing on the areas of data collection, analysis, funding, and regulatory compliance.
Assists with the implementation of clinical trial objectives to ensure successful completion of assigned projects and grants including screening and enrolling subjects into the study.
Successfully complete the Collaborative Institutional Training Initiative (CITI) courses on Research Ethics with Human Subjects and Clinical Research Coordinator (CRC), and renew certifications as required.
Successfully complete training in all research-related procedures and protocols, under the supervision of the PI and Director of Clinical Research; when necessary attend sponsor investigator/study coordinator meetings.
Gain mastery of all research project protocols, data elements, including completing source documents in the case report forms.
Ensures timeliness and integrity of data entry.
Accurately address “queries” from the Sponsor, PI, and Director of Clinical Research.
Conducts clinical research in compliance with all applicable regulations and clinical protocols.
Must be diligent in handling and shipping of human samples as well as dispensing study medications.
Interact effectively with patients with an awareness of, and sensitivity to issues related to specific disabilities, age, gender, and /or cultural background that may affect research participation.
Complete data assessment forms and survey instruments accurately in a timely manner in cooperation with Hospital for Special Care staff, while following institutionally approved protocols.
Assist in problem-solving any issues that arise.
Meet or exceed established benchmarks for data quality, recruitment, and follow-up rates, and address shortfalls immediately in line with continuous quality improvement practices.
Assist with preparation of Institutional Review Board (IRB) paperwork.
Prepare information necessary for reports of project updates.
Inform the PI, Co-Investigator, and Director of Clinical Research immediately of any crisis situations pertaining to patient/subject welfare.
Communicate effectively with the PI, Co-Investigator and Director of Clinical Research about protocol compliance and research project progress.
Provide input and insight into the refinement of study protocols and procedures as part of our constant quality improvement initiative.