Clinical Project Associate Jobs

Strong time management, problem-solving, and organizational skills

Provide project management and operational support to designated clinical project team ensuring that quality, timelines, and project specifications are met

Manage study documentation ensuring accuracy within the documentation while aiding in the preparation of supply shipments to study sites

Associate degree or at least 1 year work experience

Medical device/medical terminology and photography experience is advantageous

HIPPA/GCP guidelines knowledge is a plus

Drives functional excellence in education, implementation and compliance to best practices and shares lessons learned for trial management.

An onboarding partner in case of no prior people management experience.

Strong project management skills and demonstrated ability to meet timelines.

an onboarding partner in case of no prior people management experience.

Drives the implementation, maintenance and resolution of clinical trial quality risk management process within the CTT.

Leads development of clinical outsourcing specifications and management of interface with Contract Research Organization.

Assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial

Set-up, document collection/upload of files to the TMF/eTMF

Perform initial quality review of documents prior to upload/filing in the TMF/eTMF

Partner with document specialist to maintain the Trial Master File (TMF) in “audit ready” condition from study start to completion

Review study documents to ensure they are current, complete and accurate

It’s More Than a Career, It’s a Mission.

Extensive clinical project management experience, with at least 5 years of clinical project management experience

Responsible for overall quality and management of the delivery clinical trial projects and programs

Manages complex, cross-functional resource requirements in line with budgeted, time, scope, and quality expectations for project delivery

Ensures effective risk management across the project delivery lifecycle

Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements

Strong general administrative skills and experience

Some experience with operational management and budget planning

Minimum requirement: 10+ years of experience in clinical operations

Significant experience leading clinical projects

Experience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teams

You have experience working in a fast-growing, dynamic company (or a strong desire to)

Requirements - What You Must Have

Experience with operational management and budget planning

Ensure close and transparent communication between the CDT and the Clinical Management Team (CMT)

Minimum requirement of 12 or more years of experience in clinical operations

Significant experience in leading and managing complex clinical projects/programs

Significant experience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teams

Global clinical program level experience required

Experience in clinical trial regulations (e.g. GCP, ICH), budgeting, operations management, organizational behavior, and leadership to guide the clinical operation team.

Associate Director, Clinical Operations/Project Management

Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline with an advanced degree preferred.

Ability to lead a team of remote workers in a virtual environment.

Excellent leader and team player; willingness and ability to fill functional gaps in a small organization.

1 - 3 years of clinical drug supply management, clinical supply chain, clinical supplies, hospital pharmacy, pharmacy experience or equivalent required

IRT design and management experience preferred

Experience with Clinical Supply Inventory Management systems preferred

Prior Cold Chain packaging, labeling, distribution experience preferred

Proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)

Experience in maintaining relationships with vendors preferred

Completes a variety of other clinical trial and project management-related responsibilities as assigned and agreed upon with direct manager

Uses time efficiently, completes tasks correctly and on time, follows instructions and responds to management direction

Coordinates and assists with team finance meetings

Previous clinical experience a plus; basic understanding of clinical trial processes is required

Strong attention to detail and excellent communication and organizational skills

Strong computer skills required including MS Office (Word, PowerPoint, MS Project), including a high-level proficiency /expertise in Excel

Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation). Working knowledge of medical and scientific terminology.

Experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

Strong experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

Strong experience in clinical trials research.

Experience completing clinical trials case report forms via hard copy and online.

3-5 years clinical study management experience

Minimum: 5 years clinical study management experience

Manage clinical operations for post-market observational registry at study sites in the US

Manage sites by tracking regulatory submissions/approvals, patient recruitment, case report form completion and data queries.

Administer electronic data capture (EDC) system for data entry by study site staff.

Manage invoices from contracted study sites and vendors.

You will assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial

You will set-up, document collection/upload of files to the TMF/eTMF

You will perform initial quality review of documents prior to upload/filing in the TMF/eTMF

You review study documents to ensure they are current, complete and accurate

It’s More Than a Career, It’s a Mission.

About Sarah Cannon Research Institute