Lead Clinical Research Associate
Clinical Operations /
We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries.
What fuels our focus? Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones. We show up every day committed to do work that matters. When you join ProTrials, you will join a collaborative community helping to build a healthier world.
We also understand your need to balance a meaningful workload with life’s every-day moments. At ProTrials, we know that this makes our employees happier, healthier, and more successful.
Come join us in doing work that matters!
This person will play a crucial role in being responsible for tasks that relate to the operations and management of clinical trials. The Lead Clinical Research Associate may be located in-house at ProTrials, a client’s office, or be regionally based. The Lead Clinical Research Associate may be involved in some or all of the tasks listed below.
- Acting as primary liaison between the study site staff and Sponsor Company
- Overseeing the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples
- Training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
- Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
- Reviewing investigational product accountability, including discrepancy resolution
- Processing or overseeing transmission of study data to sponsor according to protocol-specified timelines
- Reviewing data queries and listings, and working with the study site staff to resolve data discrepancies
- Visit report writing and site correspondence
- Monitoring clinical studies of investigational and approved products. This may include qualification, initiation, interim monitoring, and close out site visits
- Monitoring studies by reviewing and reporting to the Sponsor on the following: site enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalities
- Interacting with project manager (sponsor or other) through formal and informal communications, including providing updates, identifying issues, sharing of information and instructions
- Supervision and guidance of CRAs, CTAs, and external CROs. Conduct co-monitoring, training and audit visits. Creation of visit report templates. Review of completed visit reports
- Visit report writing and site correspondence
- Managing the resource requirements of the project
- Interdepartmental liaison working with regulatory, data management, biostatistics and clinical groups to develop and maintain clinical plan
- Document/Supply Tracking:
- Managing the preparation, collection and maintenance of trial regulatory documents
- Maintaining study files to ensure all appropriate documentation is present
- Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
- Managing investigational product ordering, packaging, labeling and ongoing inventory
- Document/Presentation Preparation:
- Managing the reporting of serious adverse events
- Developing study-related documents such as protocols, case report forms, informed consent forms, study binders, standard operating procedures, study guidelines, study management/tracking tools, and monitoring plans
- Preparing contracts with investigators/hospitals, and negotiating budgets and payment schedules
- Planning, preparing for, and giving presentations at investigator meetings
- Development and management of study timelines
- Assisting with medical writing and regulatory submissions, such as interim, final study, and annual progress reports. Developing or updating Investigational Product Brochures. Preparing documentation for regulatory submissions (IND, NDA, BLA, IDE, PMA)
- Detail oriented
- Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
- Flexibility with changing priorities
- Ability to efficiently perform and prioritize multiple tasks
- Familiarity with medical and pharmaceutical industry, and related terminology and practices
- Extensive knowledge of FDA regulations and their practical implementation
- Willingness to travel
- Computer proficiency in Microsoft Word, Excel, and PowerPoint
EDUCATION AND/OR EXPERIENCE
- RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experience.
PERKS AND BENEFITS
- Competitive pay
- Career growth
- Full medical, dental, and vision benefit packages
- Commuter benefits
- Legal benefits
- The best coworkers, if we do say so ourselves
ProTrials Research, Inc. is an equal opportunity employer. ProTrials does not discriminate against qualified applicants or employees with respect to any terms or conditions of employment based on race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.