Field Clinical Research Associate Jobs

At least two years of experience as a clinical research associate

Excellent writing, editing, and communication skills

Strong Administrative and Organizational skills to support several team members

A bachelors degree in Health Sciences, Nursing or Medical Biotechnology, or Biological Sciences

Familiarity with various computer document formats, styles, and standards

· Collecting, analyzing, and recording data

The Clinical Research Intern will apply analytical, project management skills and enthusiasm for healthcare and commitment to improving healthcare through research.

The candidate will Product practical experience within the Clinical Research operations at ***.

Complies with established policies, health and safety regulations and requirements, procedures, and department objectives.

Bachelor's Degree in biological or life sciences or health related field OR attending/completed a clinical research certification program.

Proficient computer skills using Microsoft Office products.

May assist with follow up and closing of clinical studies.

Able to manage multiple and competing priorities through effective organizational management skills.

Effective interpersonal skills; able to build effective relationships with study management team colleagues and business partners.

Excellent time management skills; able to accomplish established goals efficiently.

Supply chain management support may include:

Support Trial Management team member with assigned study specific projects and tasks.

Two years Clinical Research work experience, or relevant experience

Clinical Trial Collaboration: Work alongside our clinical team, focusing on site qualification, initiation, management, and data integrity.

Data Management: Oversee data activities, generate, and resolve queries, and report on study metrics including enrollment and adverse events documentation.

Regulatory Oversight: Manage investigational product accountability, monitor IRB requirements, and ensure prompt processing of regulatory documents.

Bachelor’s degree in a medical/scientific field, with 4+ years of clinical research experience (Master’s degree can substitute for 1 year).

Strong organizational, multitasking, and relationship-building abilities.

Effective communication skills and keen attention to detail.

5+ years of CRA experience.

3+ years of experience working on oncology studies.

BS in a relevant scientific discipline.

Ability to travel and be on-site. (Austin, TX or Portland, OR).

6-month contract. - 40 hours per week. - Monday to Friday.

Austin, TX or Portland, OR

Effective time management skills required with a demonstrated ability to assess and prioritize opportunity required.

Market knowledge and experience selling to OB/GYN or MFM strongly preferred.

Minimum three years’ physician sales experience in diagnostic laboratory business (preferably in a genetics laboratory).

Excellent organizational and communication skills (written and verbal) with demonstrated ability to effectively present to both internal and external customers.

Increasing revenue and driving market development through direct sales to individual MFMs, Ob/Gyns and Genetic Counselors.

Sales efforts include effective prospecting, cultivating and maintaining key relationships.

Minimum of four (4) years of experience in clinical research specifically in Ophthalmology surgical medical devices.

Experience in glaucoma devices is strongly preferred.

Knowledge of medical and ophthalmology terminology

Remotely monitor data and support clinical sites for protocol compliance and recruitment activities

Manage clinical trial close-out activities, including return of investigational product, final reconciliation of all required documentation, and EDC close-out

** Candidates must have experience in Ophthalmology Clinical Research trials to be considered!

• Maintains on-going professional education on clinical trials and research

• Minimum requirement: master’s degree in nursing/Healthcare related field

• Clinical work experience in oncology

• Excellent organizational and communications skills, with team-player proven ability to meet project deadlines

• Knowledge of data analytics

• Serves as a liaison to industry sponsored, consortium and Investigator initiated Brain Tumor Trials

Good understanding of Clinical Study Management including monitoring, study drug handling and data management

1.5+ years of CRA experience in Cardiovascular/Metabolic, Respiratory and/or Immunology therapeutic experience

Fluent knowledge of spoken and written English

Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP

Good knowledge of relevant local regulations

Good medical knowledge in relevant AZ Therapeutic Areas

·3+ years of clinical monitoring or site management experience.

Delivers high quality and timely reports following each site management or site monitoring visit.

May include managing query resolution process with clinical sites and data management groups.

·Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements.

·Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.).

Prepares for and conducts site qualification and site initiation, visits. May also include interim and closeout monitoring visits.

Knowledge of project management tools and practices, and proficiency in using normal office software; Microsoft Word, Excel and PowerPoint.

Participate in maintaining accuracy within clinical management systems and internal reports and trackers.

Able to manage multiple projects independently and use varying databases and management systems.

Minimum 1-3 years relevant clinical research experience.

Excellent verbal and written communication skills, good organizational and interpersonal skills, and a team drive.

Knowledge of GCP and FDA regulations related to clinical trial conduct and familiarity with industry best practices.

Experience in clinical study management required.

Manages Trial Management Filing (TMF) system, including document inspection, filing, and auditing.

Serves as key facilitator and liaison for shipping, receiving, and management of study devices.

Ability to constructively interact directly with senior management teams.

Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.

Manages study and site materials, including, but not limited to study binders, study trackers, training documentation.

Familiar with industry CTMS and data management systems

Provides site level management for established protocols and portfolio under general supervision

Project Management - Communicates changes and progress; Completes projects on time and budget.

Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues

Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

Excellent communication and interpersonal skills

Shipping/ labeling/Site Management and Team meeting facilitator

Database Lock (listing review as needed/ Data query & resolution/Source data verification – onsite or remotely)

Read more about our employee benefits.

Generation of Study Documents (Clinical Monitoring Plans/ Informed Consents/ data source work sheets/Device accountability/training slides and work instructions)

Site start up to Site Activation (SA) to include Investigator Site File/Inventory and Device

Study Duration (Enrollment tracking/Key Performance Indicators/Adverse Events/ Serious Adverse Events)

Site management and monitoring activities across all US clinics

Minimum of 2 years work experience as a Clinical Research Associate

You should be life science degree educated with independent on-site monitoring experience.

Flexibility and ability to travel are paramount with strong communication, written and presentation skills.

Must have experience in Dermatology and Ophthalmology studies.

Work with sites to adapt, drive and track subject recruitment plan

Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.

Excellent time management and social skills

Minimum of 2 years of active independent field monitoring experience - all types of visits.

Strong interpersonal, written, and verbal communication skills within a matrixed team.

Experience working in a self-driven capacity, with a sense of urgency and limited oversight.

Benefits Of Working With Parexel FSP

Proven Skills in Site Management, including management of site performance and patient recruitment.

Effective time management, organizational and interactive skills, conflict management, problem solving skills.

Performs clinical study site management/monitoring activities;

Performs remote and on-site monitoring & oversight activities.

Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations;

Mininum 2 years of direct site monitoring experience in a bio/pharma/medical industry.

Experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support

Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology

Ability to identify customer requirements and manage expectations for clinical studies

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)

Working knowledge of clinical research methods and practices for medical devices, including IDE and CE Mark studies.

Detail oriented, with solid organization and time management skills

Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements

Provide guidance to sites including protocol interpretation and eligibility requirements

Conduct site visits including (but not limited to) site qualification visit, site initiation visits, interim montoring visits, study close-out visits.

Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues as needed

Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors

Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.

Effective time and financial management skills.

Alternatively, you should have an equivalent combination of education, training and experience

A Bachelor's degree in a health care or other scientific discipline or educational equivalent

Good therapeutic and protocol knowledge as provided in company training.

Written and verbal communication skills including good command of English language.