Clinical Research Associate CRA II-Principal Regional/Remote

Regional Clinical Research Associate - Must have 1+ years of traveling CRA exp with a CRO or Sponsor

(CRA II Principle CRA)

$95,000-$130,000

• Positions available in these states:
  CA, OR, WA, AZ, CO, UT, MT, WY, ID, NV, NM, KS, NE, SD

• Regional travel, work from home, direct hire opportunities

• CRA II - 1+ years of exp
• Sr CRA I - 2+ years of exp
• Sr.
  CRA II - 3+ years of exp
• Principal CRA - 5+ years of exp

Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers.
We currently have exciting opportunities for permanent Clinical Research Associates at various levels to work with one of the largest global CRO in the industry.
We are currently hiring CRA s with at least 2 years of experience all the way up to Principle CRA s who have several years of monitoring experience.
Our client is regionally aligned so you will support sites within your region vs therapeutically aligned.
This opportunity is offering excellent benefits, employee perks and long lasting career path for growth potential in the future.

Summarized Purpose:

Performs and coordinates all aspects of the clinical monitoring and site management process.
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.).
Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability.
Ensures audit readiness.
Develops collaborative relationships with investigational sites.
Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions:

• Monitors investigator sites with a risk-based monitoring approach:
  applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
  Assess investigational product through physical inventory and records review.
  Documents observations in reports and letters in a timely manner using approved business writing standards.
  Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
  Conducts monitoring tasks in accordance with the approved monitoring plan.
  Participates in the investigator payment process.
  Ensures a shared responsibility with other project team members on issues/findings resolution.
  Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary.
  Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
  Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
  Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
  Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and the clients project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.

Knowledge, Skills, and Abilities:

• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documents
• Well-developed critical thinking skills, including but not limited to:
  critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as require
• Good computer skills:
  solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

Job Qualification

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Minimum 1 year of onsite monitoring experience as a traveling CRA supporting sponsor initiated studies to be considered for CRA II.
  You will be hired into your title depending on years of onsite/remote based monitoring industry experience you have gained.
• Valid driver's license where applicable.
• This role requires independent travel that go up to 80% at times, inclusive of traveling in automobiles, airplanes, and trains.
• All U.S.
  new hires must be fully vaccinated before their first day of employment or request an accommodation.
  New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.