CLINICAL RESEARCH ASSOCIATE

Full Time, Temporary

Summary

Monitors and/or supervises the monitoring activities of assigned clinical trials for new products to ensure adherence to Federal regulations, company policies, and any other applicable procedures. Acts as project resource to study, site, CRO and in-house personnel regarding the product under test and the clinical trial conduct. Works under the direction of the Clinical Project Manager.

Responsibilities and Essential Duties:

Assist in the oversight and management of Global clinical trials

Establish and maintain communication with clinical sites and CRO

Organize and participate in investigator meetings

Conduct site pre-investigational visits, site initiation visits, and closeout visits.

Conduct on-site clinical monitoring and in-house monitoring review which includes: document review, ensuring accurate data recording, verifying patient data, adherence to the protocol of a clinical trial, drug accountability in accordance with good Clinical Practices (GCP), the Code of Federal Regulations (CFR), and company SOPs.

Review/prepare trip reports, recommending corrective action where appropriate; maintain regular telephone contact with sites and/or CRO; maintain written correspondence with site and CRO.

Assist the Clinical Project Manager with communication to investigational clinical sites to obtain study status.

Assist in the review of Case Report Form (CRFs) design for research data collection of subject safety and efficacy parameters as required by the study protocol, federal regulations, and GCP.

Acts as sponsor liaison to resolve any site related issues quickly and effectively in conjunction with the Clinical Project Manager

Participates in development of study related documents including informed consent form template, monitoring plan, template source documents, study manual, regulatory binder, pharmacy binder and other resource materials.

Participates in the review of the protocol and amendments, Investigator Brochure, and CRFs

Facilitates IRB/EC submission, queries and approval process.

Assists in clinical site contract and budget development and negotiation

Participates in managing distribution, collection and tracking of regulatory documentation to ensure site and sponsor compliance and audit readiness.

Participates in coordinating preparation of training materials for site initiation, CRO, contract monitor training and mentoring of new clinical team members.

Assist in query resolution; Identifies and gathers missing or incomplete data from clinical sites

Enters CRF and/or Source data into clinical database

Interacts with medical affairs and other corporate staff in achieving corporate objectives

Other duties as assigned

Willing to Travel up to 50% (international and domestic)

Qualifications

BS degree required. Degree in science/health related field preferred.

Experience in a clinical healthcare setting preferred.

2-3 years clinical research experience required in a pharmaceutical, biotech or CRO setting.

Medical Device and global trial experience a plus.

Clinical experience as respiratory therapist, nurse, pharmacist or pulmonary study experience is a plus.

Excellent interpersonal, organization skills

Ability to work in a fast paced, dynamic setting

Ability to manage multiple tasks in a collaborative environment

Excellent written, communication, medical terminology and computer skills

Working knowledge of GCP, ICH and FDA regulations

Ability to work in a medical setting and interface, communicate and train medical team members

Detail oriented, strong problem solving skills

Positive, self motivated team player

Please send resumes to Leslie Simpson, leslie.simpson@aerist.com