Clinical Research Associate, Evidence
Location: Morrisville, North Carolina, United States
Requisition Number: 822
Position Title: Clinical Research Associate, Evidence
The Clinical Research Associate (CRA), Evidence (Real-World Evidence [RWE]) is responsible for managing the research activities at sites participating in Worldwide’s clinical research projects, which are predominantly registries and other types of non-interventional / observational studies. The CRA will typically be involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded.
While most of the site management efforts will be performed remotely, some on-site management activities will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements.
- Assisting with the development of study documents, such as informed consent forms, submission documents, etc.
- Coordinating with the Institutional Review Boards, Research Committees and/or Ethics Committees, which safeguard the rights, safety, and well-being of all study participants
- Assisting with the management of regulatory authority applications and approvals
- Assessing the suitability of potential investigators, as well as their staff, infrastructure and facilities for participation in research activities
- Providing prompt update regarding site recruitment activities, including reasons why potential sites have declined participation in the study
- Assisting with the negotiation of contracts and budgets with potential sites
- Overseeing set-up activities at study sites, which includes ensuring each site has all appropriate study materials
- Conducting study initiation visits (SIVs)
- Providing training to the sites regarding the study design, obtaining informed consent, collection of data (including patient-reported outcomes), reporting of potential safety-related events, etc.
- Serving as the point of first contact when investigators/site personnel to address any questions or concerns participating sites may have
- Monitoring site activities throughout the study, including patient enrollment and follow-up, collection and entry of data, and providing the IRBs/RCs/ECs with updates as appropriate
- Tracking data collected and entered by participating sites, and generate queries are required to obtain any required clarification
- Participating in conference calls and other meetings to review study progress
- Ensuring that participating sites are adhering to Worldwide and/or sponsor SOPs, and that they adhering to appropriate research standards, such as Good Pharmacoepidemiological Practices
- Performing source document verification as appropriate, with particular emphasis on proper collection of informed consent, adherence to regulatory requirements, and reporting of potential safety-related events;
- Preparing visit reports in a timely and effective manner
- Maintaining appropriate project files, including IRB/RC/EC approvals, study binders, protocols, case report form completion instructions, consent documents, etc
- Closing down study sites on completion of the research effort
- Archiving study documentation and correspondence
OTHER SKILLS AND ABILITIES:
- Excellent written, verbal and presentation skills
- Superior organizational skills with attention to details
- Ability to work with little or no supervision
- Ability to use diplomacy and tact when dealing with problems
- Ability to identify problems and determine the best course of action for their resolution
- Ability to critically evaluate the information for accuracy and usefulness in solving problems
- Excellent written, verbal and presentation skills
- Ability to use standard office equipment such as a computer, keyboard, etc., and proficiency with standard software, such as Word, Excel, etc.
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science and a minimum experience of two years in clinical research (e.g. study coordinator, CTA, CRA I, etc.), OR
- Two-year nursing degree and two years as a Clinical Research Associate Level I
- One or more years of experience with Phase IV, Post-Approval, Late Stage, Health Economics and Outcomes Research or Observational Studies
- Ability to travel is required
- Proficient in the use of computers
- Experience with relevant software and paper and electronic data collection systems
- Excellent verbal and written communication skills
- Ability to work independently
- Excellent problem solving and time management skills
Worldwide Clinical Trials is an Equal Opportunity Employer
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Clinical Research Associate, Evidence
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Morrisville, North Carolina US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.