Senior Clinical Research Associate - CNS - West Region

Senior Clinical Research Associate - CNS - West Region page is loaded

Senior Clinical Research Associate - CNS - West Region

remote type

Remote

locations

Research Triangle Park, North Carolina

time type

Full time

posted on

Posted 3 Days Ago

job requisition id

JR101018

Who we are

We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

*SUMMARY: **Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.*

*RESPONSIBILITIES:*

_Tasks may include but are not limited to:_

Perform feasibility studies for potential sites as requested

Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements

Function in the role of Lead CRA for global studies, coordinating CRAs

Develop Clinical Monitoring Plan as requested

Conduct site visit trip report review and provide feedback and edits

Provide mentoring and guidance to less experienced CRAs and site staff when needed

Design study specific tools and templates as requested

Actively participate in study team and investigator meetings

Actively participate in bid defenses

Create and conduct training to study team members or colleagues as requested and appropriate

Work with Project Management to evaluate deliverables and study milestones

Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)

Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site

Document site visit findings via written reports

Provide input into the design of protocols and CRFs as requested

Assess, monitor, and train study site staff on protocol adherence as required

Review study subject safety information and informed consent

Conduct source document verification for compliance, patient safety, and veracity of data

Review CRFs using paper or electronic data capture systems and assist sites with data query resolution

Assist the site in maintenance of the Investigator Site File

Maintain regular communication with sites

Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)

Ensure site compliance with IP receipt, accountability and return or destruction

Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate

Complete final site close out visit and report

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

*OTHER SKILLS AND ABILITIES: *

Excellent oral and written communication skills

Excellent planning and organizational skills with effective time management

Excellent interpersonal skills

Demonstrate initiative and problem solving skills

Ability to lead and motivate assigned team (if applicable)

Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities

Extensive understanding of clinical research principles and process

Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements

Thorough understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriate

Thorough understanding of standard operating procedures

Proficiency in Microsoft Office

Proficiency with IxRS, EDC systems

*REQUIREMENTS:*

Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc. ) and with a minimum experience of three years as a Clinical Research Associate OR

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 five years as a Clinical Research Associate, OR

Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree preferred) and a minimum seven years as a Clinical Research Associate

Willingness to travel required

Valid current passport required

Driving license required

Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

We love knowing that someone is going to have a better life because of the work we do.