Company

KCR

Advertisement

Junior Clinical Trial Documentation Associate | United States

Publication

2021-10-12

Company description

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.comWe see human behind every number.

 

JUNIOR CLINICAL TRIAL DOCUMENTATION ASSOCIATE

Location: United States (home-based)

 

Due to KCR’s global organization growth, we seek for an enthusiastic and committed jnior CTDA to be responsible for TMF set up, review, oversight and archiving for clinical research studies according to project-specific guidelines, Standard Operating Procedures, GCP Guidelines and local law.

 

Scope of responsibilities:

  • Prepares and is responsible for assigned Trial Master File setup, conduct and close out in cooperation and under the guidance of more senior staff and KCR functional area project team members;
  • Monitors the TMF routinely for document availability using defined tools and/or routine procedures according to agreed upon metrics and performs escalation per process definition;
  • Performs high-level administrative review of assigned TMF parts according to established timelines; informs TMF document owners about required corrective actions and missing documentation or other deficiencies;
  • Follows up all issues for resolution after the high-level administrative review;
  • Executes compliance check for expected documents;
  • Liaises with KCR functional area project team members and document owners in the scope of assigned activities and projects for TMF related needs;
  • Communicates availability of new or updated Trial Master File set up documents to Study Team;
  • Sets up and conducts TMF Review Meeting;
  • Manages and enforces the creation of binders and placeholders;
  • Generates the QC Plan for QC Check execution and evaluates QC check results compared to threshold;
  • Assures that eCMS is complete and up-to-date during the study and performs eCMS archival process;
  • Participates and coordinates preparation of the completed studies for archiving;
  • Plans TMF delivery to Sponsor and executes shipment of complete TMF to Sponsor;
  • Performs final QC check and archives “wet ink” originals for KCR;
  • Creates workbooks and records site information in CTMS at the study start up.

Qualifications:

  • Clinical research experience is an advantage;
  • Fluency in English;
  • Good organization skills, patience, attention to details;
  • Knowledge of GCP including a basic understanding of regulatory requirements;
  • Knowledge of the local law related to the clinical trials conducting;
  • University / college degree (life science preferred);
  • Very good communication skills (both verbal and written);
  • Eagerness to learn medical / clinical research vocabulary and procedures;
  • Teamwork ability;
  • Computer competency.

At KCR, we put our mission: we see human behind every number into our actions, therefore we offer Our Employees benefits that are being reviewed on a regular basis and to comply with national regulations and to ensure that we provide the coverage that best meets employee needs.

To show that you are appreciated in our team, prove our appreciation, while working at KCR you will be provided all employees with the following:

 

  • Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry;
  • Efficient Onboarding process to enable you fast takeover of duties;
  • Peer/ Buddy/ Mentor who will introduce you to the organization;
  • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed;
  • Empowering workspace, offering opportunities to share ideas and influence company services development worldwide;
  • Mentoring and training programs related with in clinical trials, therapeutic areas, soft skills development.