Clinical Research Coordinator I

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

Compensation starts at $52,243 per year, with the final annual salary determined by the candidate's relevant experience and qualifications.

Qualifications

Knowledge, Skills and Abilities

- Knowledge of appropriate medical terminology.

- Knowledge of appropriate email etiquette and effective communication.

- Knowledge of clinical study affairs and issues.

- Ability to work scheduled hours as defined in the job offer and to use time effectively.

- 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 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

- Bachelors degree from a four-year college or university, one to two years related experience and/or training, or equivalent combination of education and experience.

- Patient care experience is highly desired.

- Legible handwriting is a requirement.

- Phlebotomy experience desired but not required.

- GCP certification, IATA certification desired but not required for consideration.

- Current drivers license and reliable vehicle

- Certification by the Association of Clinical Research Professionals (ACRP) or similar organization is preferred but not required.

- Ability to learn new tasks and apply skills and knowledge to various work activities.

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.

- Ability to look at a computer screen for many hours of the day.

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 (*).