Clinical Research Coordinator I

Description

Position Summary

The Clinical Research Coordinator I conduct high quality clinical research following the highest ethical and regulatory standards of care.

Major Duties and Responsibilities

· Become familiar with the design of proposed and implemented studies.

· Review  study protocols to evaluate factors such as sample collection processes, data management plans, and potential risks to subject patients.

· Communicate well with patients, medical personnel, research sponsors, and institutional review boards (IRBs).

· Assess eligibility of potential subjects through screening interviews, review of medical records, and discussion of patient status with physicians and nurses.

· Inform patients and caregivers of study designs, risks, and outcomes to be expected.

· Organize sites for study equipment and supplies.

· Contact industry representatives to ensure that the equipment and software specifications needed for successful study completion are available.

· Attend meetings required by research sponsors; some travel and overnight stays may be required.

· Enroll patients in clinical studies, ensuring that informed consent is obtained and documented in accordance with all applicable regulatory and ethical requirements at the federal, state, and local levels.

· Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.

· Order the drugs and/or devices necessary for studies.

· Dispense medication and/or medical devices, calculate dosages, and provide instruction for patients as necessary.

· Comfortable handling lab specimens which may include blood, urine, vaginal fluids, joint aspirants, sputum or others.

· Competent in the processing, labeling specimen tubes, filling out requisitions, working with dry ice, storing and shipping lab specimens as required.

· Collect and maintain study data, which may be either electronic and/or printed, depending on the study.

· Obtain subject follow-up information and communicate with health care providers and subjects as necessary.

· Register protocol patients with appropriate statistical centers as required.

· Prepare and maintain records of study activities, including case report forms, drug dispensation records, and regulatory compliance.

· Prepare and maintain study-related protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.

· Record adverse events and side effect data and confer with investigators regarding the reporting of events to oversight agencies.

· Collaborate with investigators to prepare reports and presentations concerning clinical study procedures, results, and conclusions.

· Track enrollment status of subjects, document causes of dropout, and document efforts to contact subjects.

· Become familiar with relevant electronic medical records and HIPAA law.

· Monitor studies to ensure compliance with protocol design.

· Monitor studies to ensure compliance with federal, state and local regulations and TPMG's ethical policies.

· Prepare for and participate in audits conducted by study sponsors, federal agencies, and specifically designated review groups.

· Maintain contact with sponsors to schedule and coordinate site visits and answer questions about all issues with records or data

· Identify protocol problems, inform investigators of problems, and assist resolution of such problems

· Confer with health care professionals to determine the best recruitment practices for studies.

· Develop advertising and other informational materials to be used in subject recruitment.

· Meet with physician groups as needed.

· Participate in preparation and management of research budgets.

· Participate in the billing process for studies and oversee monetary disbursements.

· Participate in training and quality assurance programs.

· Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical study affairs and issues.

· Ability to work well independently and with a team.

· Ability to refocus attention easily after multiple interruptions.

· Ability to remain organized despite multiple paper charts being utilized at the same time.

· Using your own transportation to purchase dry ice for laboratory specimen shipments and taking the packages to USPS, UPS, and or FedEx for delivery as needed.

· Willing to perform work related tasks off-site when necessary.

· Willing and eager to learn new things.

· Other duties as assigned.

Qualifications

Knowledge, Skills and Abilities

• Knowledge of appropriate medical terminology.
• Knowledge of clinical study affairs and issues.
• Ability to work scheduled hours as defined in the job offer.
• Ability to determine appropriate course of action in more complex situations.
• Ability to present information to top management, public groups, and/or boards of directors effectively.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to manage multiple and simultaneous responsibilities.
• Ability to read and understand oral and written instructions and follow written protocols.
• Ability to prepare budgets, manage data, prepare spread sheets, and apply mathematical concepts such as probability, statistical inference, and basic concepts of algebra and geometry to practical situations.

Education / Training / Requirements

• High School Diploma/GED
• RN degree, LPN degree, bachelor's degree from a four-year college or university, one to two years related experience and/or training, or equivalent combination of education and experience.
• Current active Registered Nurse license desirable but not required.
• Certification by the Association of Clinical Research Professionals (ACRP) or similar organization is preferred but not required.

Physical Demands

• Ability to stand and walk for long periods of time.
• Ability to sit for extended periods of time.
• Ability to climb or balance for limited periods of time.
• Ability to occasionally reach, bend, stoop and lift up to 50 lbs. *
• Ability to grasp and hold up to 25 lbs.*
• Ability to hear normal voice level communications in person or through the telephone.
• Ability to speak clearly and understandably.
• Ability to taste and smell.

Success Factors

• Alignment with Company Mission and Core Values
• Excellent Time Management/Organized
• Open Communication/Positive
• Goal Driven
• Excellent Customer Service
• Juggles Multiple Priorities
• Accuracy and Attention to Detail
• Accomplished in word processing and worksheet utilization

All statements are essential functions of the position unless identified as non-essential by an asterisk (*).