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DescriptionJob Location: IN 2630 Grant Line Road 0VQ50 - New Albany, IN
Salary Range: Undisclosed
Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards.
Supervisory Responsibility: This position has no supervisory responsibilities
Key Responsibilities
- Administratively and clinically manage industry sponsored clinical trials.
- Adhere to Research SOPs, Good Clinical Practices, and the study protocols.
- Assist in patient recruitment by performing detailed chart reviews and patient interviews.
- Discuss study protocols with patients and verify the informed consent documentation.
- Review medical history of patient against inclusion/exclusion criteria of studies.
- Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations.
- Schedule all patient research visits and procedures consistent with protocol requirements.
- Dispense study medication, collect vital signs, and perform ECGs.
- Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
- Complete and maintain case report forms per FDA guidelines and review them against the patients medical record for completeness and accuracy.
- Function in a clinical role by conducting clinical research studies.
- Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes.
- Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients.
- Maintain compliance of protocols and regulatory guidelines for studies performed in the research area.
- Act as a resource for other staff members regarding investigational issues or guidelines.
- Coordinate the availability and distribution of medications for patients in a timely manner.
- Perform phlebotomy for lab work as required and completes all necessary forms.
- Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved.
- Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures.
- Assist the principal investigator and research director with various administrative tasks associated with the day-to-day operations of research studies and projects.
- Plan and coordinate with the research director the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity.
- Plan, implement, and maintain data collection and analysis systems in support of the research protocol.
- Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
- Facilitate assigned clinical trial from start to finish.
- Screen participants for all studies independently.
- Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
- Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required.
- Adhere to infection control/safety guidelines and confidentiality policies.
Core Competencies
- Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized, Self-motivated
General
- Adopt the One GI culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers.
- Incorporate a leadership mindset to your role.
- Comply with One GI procedures, policies, and regulations relevant to your role.
- Successfully completes all One GI training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.)
- Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws.
- Computer skills good working knowledge of MS office.
- Ability to communicate effectively with others, both verbally and in writing.
- Proven ability to manage time, meet deadlines and prioritize.
- Able to maintain standards and professionalism during periods of fluctuating workloads.
- Provide professional service to direct customers of One GI in all interactions.
- Build effective working relationships with other team members.
- Manage daily tasks to ensure business needs are consistently met.
Education and Qualifications
- High School Diploma or equivalent required.
- Associates degree in a clinical or scientific related discipline required.
- Bachelor's degree preferred.
- One (1) year previous experience as a clinical research coordinator for pharmaceutical phase II or III trials required.
- Previous GI trials experience preferred.
- Clinical experience in an office or hospital setting.
- Research experience or equivalent.
- Must maintain current licensure and/or certification.
- BLS certified.
- Knowledge of medical terminology, anatomy, physiology, and pathophysiology.
- Familiarity with health care systems, regulations, policies, and functions.
- Understanding of clinical research documentation standards.
- Knowledge of equipment, supplies, and materials needed for medical treatment.
- Understanding of basic laboratory procedures including phlebotomy, preparation, and screening.
- Working knowledge of industry standards and regulatory requirements relevant to clinical drug trails.
- Registered Nurse with five (5) years experience required.
- BSN preferable.
- Membership in local, state and national societies is encouraged.
- Understanding of Code of Federal Regulations for Human Subjects.
- Certified in GCPs and HSP.
- Periodic local travel to other practice locations on an as-needed basis.
- Phlebotomy experience preferred.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to speak and hear. Understand/comprehend English as well as read/follow written English instructions.
This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching. It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35+ or more. Must be able to differentiate colors and successfully pass color blind screening.
Work Environment
This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids. Involves exposure to Glutaraldehyde/Rapicide (Refer to SDS manual as needed). Occasional exposure to communicable diseases and biohazards.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Accommodations
Reasonable accommodations will be made to enable a qualified individual with a disability to perform the non-essential or essential functions of this job. All accommodations will be investigated on an individual basis with the needs of the department and current staff resources considered. Accommodations will not be made that compromise the safety and health of any associate.
