- With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
- Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor prior to, during and after the conduct of clinical trials.
- Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
- Procures equipment and supplies needed to fulfill project requirements
- Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness.
- Attends to query resolution in a timely manner.
- Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice
- Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
- With direction, assists with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical data that has been entered on the case report forms (paper or electronic) or in reports
- With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance
- Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
- Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements.
- With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials and remain eligible for continued participation.
- Engages in open and positive communication with study participants and coworkers
- With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required
- The responsibilities listed are a general overview of the position and additional duties may be assigned
- 1+ years of clinical research experience
- Phlebotomy experience (preferred not required)
- Oncology experience (preferred)
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Clinical Research Coordinator, Oncology - Albuquerque, United States - Medix
Description
Medix is hiring a Clinical Research Coordinator in Albuquerque, New Mexico to support oncology clinical research trials. This is an on-site position working Monday- Friday within a growing clinical research organization.
Key Responsibilities
Monday-Friday, 8am-5pm
Qualifications:
Clinical Research Coordinator, Oncology professionals in Albuquerque
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Sheri Lyver
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