Clinical Research Assistant (FT TEMP)

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.

This is a Full Time Temporary position (6 months or less)

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 (*).