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Aspen Clinical Research is currently seeking qualified individuals to assist with various clinical research activities.
Please see our available positions below:
Clinical Research Coordinator
Phlebotomist
Data Entry Specialist
Clinical Assistants (Phlebotomists)
Director of Clinical Operations: Out-Patient Services
Regulatory Affairs Manager
Participant Recruiter
Please remit resume to Online Application.
Clinical Research Coordinator responsibilities include:
- Coordinating protocol procedures for various pharmaceutical and device companies.
- Study setup, study execution, enrollment and conduction of research study visits.
- The coordinator is responsible for creating accurate patient source records and CRF completion.
- Working with study patients and performing testing procedures per protocol including ECG's, cardiac telemetry, phlebotomy, collecting study questioners, processing lab samples and dispensing of study medication.
- The incumbent will be required to attend investigator meetings, site initiation meetings and monitoring visits.
- Experience in conducting clinical trials is preferred but not required.
Minimum requirements are as follows:
- Medical Assistant certificate with 2-years experience working as an MA.
- BachelorÕs or Masters degree in an allied health field.
- Phlebotomy skills or certificate
- Certification as a Clinical Research Coordinator through ACRP or SOCRA is preferred but not required.
- Strong computer literacy
- Must be a fast learner and extremely detail oriented.
- Strong ability to multi-task
The starting salary range is $18 dollars per hour. Increases above the $18 dollar salary range is dependent upon the amount of education, work related experience and certifications.
This incumbent will perform venipuncture and IV placement on Clinical trial participants. Will also greet and instruct patients in a courteous manner, verify patient identification prior to specimen collection, and distribute specimens expeditiously.
Minimum requirements are as follows:
- Strong phlebotomy skills and certification required
- Must be willing to learn IV placement. Aspen clinical research will provide training and certification upon hire.
- Strong computer literacy
- Must be a fast learner and extremely detail oriented.
- Strong ability to multi-task
The starting salary range is $12 dollars per hour. Increases above the $12 dollar starting salary is dependent upon the amount of education, work related experience and certifications.
Primary Job Responsibilities:
- Entry, tracking, review, and comprehension of clinical trials data to ensure the accuracy and consistency of the clinical databases to comply with established guidelines, study specific protocols and annotated Case Report Forms (CRFs) from source documents
- Maintain consistent approaches and standards within and across projects with provided training
- Accurate and timely data entry of Case Report Form data for multiple studies
- Entry of queries/data correction forms (DCFs) of clinical trials data for multiple studies
Education/Skill/Experience Requirements:
- Minimum of 1+ year experience in a data entry environment, medical environment a plus
- Knowledge of medical terminology
- Proficient in computers, including but not limited to MS Access, MS Word, MS Excel, MS PowerPoint
- Highly effective oral and written communication skills
- Exceptional attention to detail
Primary Job Responsibilities:
- Under the supervision of the Clinical Research Coordinator:
- Screens patients for the clinical research study assigned
- Becomes thoroughly familiar with the protocol, case report forms, informed consent, source documentation, patient diary (when applicable) and study medication(s) for the assigned research study
- Reviews and explains Informed Consent Forms with all potential study subjects for assigned protocols and answers any questions or concerns
- Assists in performing appropriate research protocol procedures which may include, but are not limited to : vital signs, pregnancy tests, blood collection and processing, ECGs, and related assessments
- Observes study participants for the onset of any adverse events and reports findings to CRCs
- Assists in recording and maintaining precise and timely progress notes, source documents, and CRFs for study participants
- Performs basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups
- Assists in Participant Recruiter responsibilities as necessary including: telephone screening, maintaining participant population databases, reporting of enrollment numbers and helping to meet established quotas for enrollment
Key Skills:
- Excellent communication skills (interpersonal, written, verbal including exceptional telephone skills)
- Well organized with a strong attention to detail
- Excellent time management skills
- Legible penmanship
- Basic computer skills (documents, spreadsheets, etc.)
Experience:
- High School diploma with one year direct clinical research experience and courses in Medical Terminology and Anatomy & Physiology, and/or Phlebotomy Certification, and/or EMT-B certification
Equivalency:
- One year experience as a Medical Assistant (or equivalent), or Associates Degree in Health Science or Medical Assistant Certification
- Knowledge of FDA guidelines preferred
Education or Certifications:
- High school diploma
- CPR certification
- Phlebotomy certification (national) preferred
Primary Job Responsibilities:
- Employee management responsibilities including but not limited to: Interviewing, hiring and assisting with training new staff, coordinating staffing schedule and assignments, and completing staff performance reviews and counseling
- Interacts/communicates with Investigator, study sponsor and regulatory monitors regarding study related issues and acts as a liaison between the site and sponsor/CRO for all assigned protocols
- Ensures site is safe and in compliance with study requirements, Company policies, ICH guidelines, FDA regulations and OSHA standards
- Provides resource planning for equipment, facilities and organization of space
- Reviews potential protocols for feasibility and logistical issues from the CRCÕs viewpoint
- Develops enrollment timelines for each study and ensures that all enrollment goals are met
- Inventories and purchases narcotics used as rescue medication for studies
- Assists with and/or assumes Clinical Research Coordinator responsibilities when necessary
- All other projects as assigned
Education/Skill/Experience Requirements:
- Current RN license (preferred), with a minimum of three years direct experience coordinating multi-level projects Equivalent: BachelorÕs Degree in Health Science, with a minimum of three years direct clinical research experience, at least one of which was in multi-level projects
- CPR Certification
- CRC Certification preferred
- Phlebotomy Certification preferred
- Demonstrated knowledge of ÒGood Clinical PracticesÓ and ICH Guidelines
- Excellent communication skills (interpersonal, written, verbal)
- Strong attention to detail
- Excellent time management skills
- Proficient in computers, including but not limited to MS Access, MS Word, MS Excel, MS PowerPoint
- Minimum of one year direct management or supervisory experience, preferably in the CRO or research site industry
Primary Job Responsibilities:
- Serve as the primary regulatory representative to Site Project Teams for assigned protocols.
- Independently provides guidance to Site Project Teams on steps necessary to comply with newly enacted regulations and guidelines.
- Determine regulatory requirements for clinical submissions to sponsor/CRO and IRB for assigned investigational and marketed products.
- Acts as a liaison between the site, sponsor/CRO and IRB pertaining to the initial submission and regular updating of all protocol related regulatory documents.
- Review and finalize documents intended for submission to the sponsor/CRO and IRB to assure compliance with regulatory standards.
- For assigned projects, provides oversight and effectively manage any regulatory submissions that are outsourced.
- Conduct independent regulatory research and present to the team.
Education/Skill/Experience Requirements:
- BachelorÕs degree or RN with current license with at least two years experience with clinical research study regulatory submission and regulation.
- Working knowledge of the drug development process including drug laws, regulations, and guidelines including but not limited to 21 CFR 50, 21 CFR 54, 21 CFR 56, 45 CFR 46, and 45 CFR 164.
- Good understanding of FDA required regulatory document process.
- Good oral and written communication skills including the ability to discuss scientific/technical data and regulatory requirements with site and sponsor/CRO personnel.
- Good knowledge of ICH guidelines regarding
Primary Job Responsibilities:
- Receives incoming phone calls from potential study subject participants and collects all pertinent information.
- Documents all potential study subject participant contact information in site study database.
- Under the direction of the CRC, utilize site contact information to place outgoing calls to find potential study subject participants for assigned protocols.
- If needed, place calls to enrolled study subject participants to make and/or confirm upcoming site visit times and dates.
Key Skills:
- Excellent communication skills (interpersonal, written, verbal including exceptional telephone skills)
- Well organized with a strong attention to detail
- Excellent time management skills and ability to work under limited supervision
- Legible penmanship
- Basic computer skills (documents, spreadsheets, etc.)
Education/Experience Requirements:
- High School Diploma and at least one year experience in sales or the customer service industries.
- Knowledge of medical terminology.
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