Clinical Research Associate – Wound Care Experience Required

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Perform site monitoring duties for clinical trials.

• Offer oversight, leadership, and direction in the management and execution of clinical trials to ensure adherence to compliance and quality standards.

• Provide guidance, supervision, and feedback to the Clinical Research Associate (CRA) team concerning project scope, Standard Operating Procedures (SOPs), timelines, and budgets.

• Review monitoring visit reports and carry out co-monitoring and evaluation visits as necessary.

• Ensure timely and appropriate investigator site visits.

• Coordinate with cross-functional departments to address clinical trial monitoring challenges.

• Assist in the development of study-specific Monitoring Plans and training presentations.

• Aid in the preparation of site ethics documents and the negotiation of site contracts.

• Deliver monthly billing information to the finance department.

• Manage study budgets and act as the sponsor referent for independent projects.

• Conduct qualification, initiation, interim, and close-out visits both remotely and on-site.

• Generate precise monitoring visit reports that encompass site issues, resolutions, protocol deviations, study progress, and enrollment statistics.

• Verify source documents and maintain the integrity of Case Report Form (CRF) data.

• Execute quality control and verification of electronic Trial Master Files (eTMF) and Trial Master Files (TMF) documents.

• Oversee investigational product accountability.

• Review site regulatory binders.

• Maintain communication with study sites regarding protocol/Good Clinical Practice (GCP) compliance, patient enrollment, and sponsor requests.

• Ensure compliance with International Council for Harmonisation (ICH) GCP, FDA regulations, and company/sponsor SOPs.

• Participate in internal, client/sponsor, scientific, and various other meetings.

• Facilitate adverse event reporting and reconcile Serious Adverse Event (SAE) reports with source documentation and CRFs.

• Resolve data discrepancies with in-house CRAs, Clinical Trial Coordinators (CTC), and data management teams.

• Identify site-related issues and devise problem-solving strategies.

• Prepare for audits at study sites.

• Collaborate with other CRAs.

• Assist in the training and onboarding of new CRAs.

• Mentor CRAs.

• Collaborate on the development and maintenance of Clinical Trial Management Systems (CTMS).

• Manage competing priorities and fulfill commitments.

• Undertake additional duties as assigned.

⛳️ Requirements

• A minimum of 2 years of experience in wound care monitoring is essential.

• Ability to foster and maintain positive relationships with Sponsors, Site, and Project Team members.

• Capability to independently manage monitoring activities.

• Quality-oriented; demonstrated ability to be meticulous, thorough, and detail-focused.

• Strong organizational skills with the capacity to multitask and operate effectively in a dynamic environment.

• Proficient in managing priorities, organizing time, and resolving issues.

• Strong analytical, negotiation, meeting management, cross-functional team, and leadership abilities.

• Willingness to travel.

• Ability to handle stress effectively.

• Professional, reliable, and disciplined.

• Skilled in addressing unstructured or ambiguous challenges.

• Proficient command of the local language, both written and spoken, in the country where monitoring activities are conducted.

• Excellent communication and interpersonal skills with a focus on customer service.

• Competent computer skills, including the use of clinical trial management systems, clinical trial databases, and electronic data capture.

• Self-motivated individual who flourishes in a collaborative yet less formal team environment.

• Knowledgeable in clinical research, ICH GCP, and local regulations.

• Familiar with regulatory and ethical requirements.

• Proficient in English.

• Bachelor of Science (BS) degree in Biology or Life Sciences.

🏝️ Benefits

• Competitive salary and compensation package.

• Opportunities for professional growth and development.

• Supportive and collaborative work environment.

• Health and wellness benefits.

• Flexible work arrangements.