Senior Associate, GCP QA at Advanced Group in Woburn, Massachusetts

Job Description:

OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a Senior Associate, GCP QA in Woburn, Massachusetts. The Senior Associate, GCP QA role will support and ensure that all systems and processes are compliant with good clinical practice (GCP) guidelines, standards, and regulations (FDA, MHRA, EMA, ICH). Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Help develop and implement GCP quality standards, policies, and procedures that comply with applicable standards, regulations, and guidelines for GCP globally


• Perform compliance review of clinical protocols, clinical study reports, investigator brochures, and other clinical documentation


• Facilitate the coordination and logistics for pre-/post-inspection and audit activities


• Assist with developing storyboards, along with functional areas and subject matter experts, to be shared during audits for key processes and programs


• Work cross functionally to build and maintain inspection-readiness content to ensure quick access to materials in the event of an inspection or audit


• Act as single point of contact to assigned study teams and attend cross-functional study team meetings


• Manage GCP vendor, clinical site, and TMF audits related to assigned study teams


• Track all findings, responses, CAPAs, etc.


• Implement and maintain Electronic Document Management Systems (EDMS)


• Draft processes and procedures to support EDMS

EXPERIENCE

• Minimum of 2 years of related experience in GCP (Clinical Research, investigator site, or Quality) required


• Strong technical knowledge of applicable GCP regulations and standards


• Demonstrated experience independently researching compliance trends and regulatory authority expectations


• Experience with EDC and EDMS preferred


• Excellent attention to detail with a professional demeanor


• Strong communication, problem-solving, and organizational skills


• Proficient in MS Office (i.e. Word, Excel, PowerPoint) and Adobe Acrobat


• Travel required - up to 20% (across US once COVID is lifted)

EDUCATION

• Minimum of Bachelor's Degree in life sciences or a related discipline required

To be a best-fit your strengths must include:

• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.


• Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.


• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.


• Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.


• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.


• Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.


It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.


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