*18 month contract to hire position* Job TitleIn-house Clinical Research Associate (In-house CRA)
LocationRaritan, NJJob summaryThe In-House Clinical Research Associate will work closely with the Lead CRA and Investigational Sites by providing support with clinical monitoring activities, assisting with the preparation, organization and follow-up of investigator, site communications and clinical monitoring tracking.Primary responsibilities
- Performs study tracking to ensure that all study files and documents are accurate, current and complete
- Performs essential document collection, review, maintenance, and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs.
- Provides general support to the Lead CRA in order to manage the investigator sites and ensure compliance
- Performs recruitment plan review and provides regular enrollment updates
- Addresses protocol questions and issues from investigational sites visits
- Performs regular reviews of data according to data review/monitoring guidelines
- Assists with resolution of investigational site/data queries.
- Confirms and track that all key site personnel have project specific training.
- Documents site and sponsor contact and study interactions in a timely and professional manner.
- Provides assessment of sample status
- Monitors tracking systems (CTMS, TMF, etc.)
- Bachelor’s degree, in biological sciences or healthcare
- 5+ years clinical trial experience (CRO, healthcare settings and industry experience are acceptable).
- Excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail.
- Strong computer proficiency in MS Office including Word, Excel, and PowerPoint.
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
- Excellent organizational and record-keeping skills.
- Ability to maintain excellent working relationships with a broad range of trial staff.
- Knowledge of GCP as relates to clinical trial management
- Ability to work well in a team environment but also independently without significant oversight. Flexibility in work hours and readiness to travel.
- Experience in Cardiovascular Therapeutic area
- IVD studies
- Medidata RAVE system
Travel Pay Rate: $48.00 per hour
Drug and background screenings requiredOn-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
One of the unique aspects of On-Board is our ability to customize solutions with each of the complimentary business verticals to satisfy our partners goals including Total Solutions.
Location/Region: Raritan, NJ (US)